APEX 5038-1-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 07613327091762), received between Aug 27, 2019 and Aug 29, 2019 — classified as 48 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (13 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.

• InjuryAug 29, 2019Patient-Device Incompatibility

  THE MANUFACTURER BECAME AWARE OF A STUDY FROM (B)(6). THE TITLE OF THIS REPORT IS ¿OPERATIVE TREATMENTS COMPARED WITH NONOPERATIVE TREATMENT OF DISPLACED MIDSHAFT CLAVICULAR FRACTURES¿ WHICH IS ASSOCIATED WITH THE STRYKER APEX SYSTEM AND PLATING SYSTEM. WITHIN THAT PUBLICATION, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED WHICH OCCURRED BETWEEN MARCH 2012 AND MAY 2015. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE LOT OR PATIENT INFORMATION FROM THE REPORT, A REVIEW OF THE COMPLAINT HANDLING DATABASE, HOWEVER, REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED BY THE HOSPITAL OR BY THE AUTHOR OF THE PUBLICATION, THEREFORE 28 COMPLAINTS WERE INITIATED RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES HARDWARE IRRITATION. 2 OUT OF 3 CASES.

  Patient problems: Irritation

  MAUDE report 8947958 ↗
• InjuryAug 29, 2019Patient-Device Incompatibility

  THE MANUFACTURER BECAME AWARE OF A STUDY FROM (B)(6). THE TITLE OF THIS REPORT IS ¿OPERATIVE TREATMENTS COMPARED WITH NONOPERATIVE TREATMENT OF DISPLACED MIDSHAFT CLAVICULAR FRACTURES¿ WHICH IS ASSOCIATED WITH THE STRYKER APEX SYSTEM AND PLATING SYSTEM. WITHIN THAT PUBLICATION, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED WHICH OCCURRED BETWEEN MARCH 2012 AND MAY 2015. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE LOT OR PATIENT INFORMATION FROM THE REPORT, A REVIEW OF THE COMPLAINT HANDLING DATABASE, HOWEVER, REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED BY THE HOSPITAL OR BY THE AUTHOR OF THE PUBLICATION, THEREFORE 28 COMPLAINTS WERE INITIATED RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES HARDWARE IRRITATION. 2 OUT OF 3 CASES.

  Patient problems: Irritation

  MAUDE report 8947935 ↗
• InjuryAug 29, 2019Patient-Device Incompatibility

  THE MANUFACTURER BECAME AWARE OF A STUDY FROM (B)(6). THE TITLE OF THIS REPORT IS ¿OPERATIVE TREATMENTS COMPARED WITH NONOPERATIVE TREATMENT OF DISPLACED MIDSHAFT CLAVICULAR FRACTURES¿ WHICH IS ASSOCIATED WITH THE STRYKER APEX SYSTEM AND PLATING SYSTEM. WITHIN THAT PUBLICATION, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED WHICH OCCURRED BETWEEN MARCH 2012 AND MAY 2015. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE LOT OR PATIENT INFORMATION FROM THE REPORT, A REVIEW OF THE COMPLAINT HANDLING DATABASE, HOWEVER, REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED BY THE HOSPITAL OR BY THE AUTHOR OF THE PUBLICATION, THEREFORE 28 COMPLAINTS WERE INITIATED RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES HARDWARE IRRITATION. 2 OUT OF 3 CASES.

  Patient problems: Irritation

  MAUDE report 8947934 ↗
• InjuryAug 29, 2019Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER BECAME AWARE OF A STUDY FROM (B)(6). THE TITLE OF THIS REPORT IS ¿OPERATIVE TREATMENTS COMPARED WITH NONOPERATIVE TREATMENT OF DISPLACED MIDSHAFT CLAVICULAR FRACTURES¿ WHICH IS ASSOCIATED WITH THE STRYKER APEX SYSTEM AND PLATING SYSTEM. WITHIN THAT PUBLICATION, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED WHICH OCCURRED BETWEEN MARCH 2012 AND MAY 2015. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE LOT OR PATIENT INFORMATION FROM THE REPORT, A REVIEW OF THE COMPLAINT HANDLING DATABASE, HOWEVER, REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED BY THE HOSPITAL OR BY THE AUTHOR OF THE PUBLICATION, THEREFORE 28 COMPLAINTS WERE INITIATED RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES HARDWARE IRRITATION. 2 OUT OF 3 CASES.

  Patient problems: Irritation

  MAUDE report 8947933 ↗
• InjuryAug 29, 2019Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER BECAME AWARE OF A STUDY FROM (B)(6). THE TITLE OF THIS REPORT IS ¿OPERATIVE TREATMENTS COMPARED WITH NONOPERATIVE TREATMENT OF DISPLACED MIDSHAFT CLAVICULAR FRACTURES¿ WHICH IS ASSOCIATED WITH THE STRYKER APEX SYSTEM AND PLATING SYSTEM. WITHIN THAT PUBLICATION, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED WHICH OCCURRED BETWEEN MARCH 2012 AND MAY 2015. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE LOT OR PATIENT INFORMATION FROM THE REPORT, A REVIEW OF THE COMPLAINT HANDLING DATABASE, HOWEVER, REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED BY THE HOSPITAL OR BY THE AUTHOR OF THE PUBLICATION, THEREFORE 28 COMPLAINTS WERE INITIATED RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES HARDWARE IRRITATION. 3 OUT OF 3 CASES.

  Patient problems: Irritation

  MAUDE report 8947896 ↗
• InjuryAug 29, 2019Patient-Device Incompatibility

  THE MANUFACTURER BECAME AWARE OF A STUDY FROM (B)(6). THE TITLE OF THIS REPORT IS ¿OPERATIVE TREATMENTS COMPARED WITH NONOPERATIVE TREATMENT OF DISPLACED MIDSHAFT CLAVICULAR FRACTURES¿ WHICH IS ASSOCIATED WITH THE STRYKER APEX SYSTEM AND PLATING SYSTEM. WITHIN THAT PUBLICATION, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED WHICH OCCURRED BETWEEN MARCH 2012 AND MAY 2015. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE LOT OR PATIENT INFORMATION FROM THE REPORT, A REVIEW OF THE COMPLAINT HANDLING DATABASE, HOWEVER, REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED BY THE HOSPITAL OR BY THE AUTHOR OF THE PUBLICATION, THEREFORE 28 COMPLAINTS WERE INITIATED RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES HARDWARE IRRITATION. 1 OUT OF 3 CASES.

  Patient problems: Irritation

  MAUDE report 8947895 ↗
• InjuryAug 29, 2019Patient-Device Incompatibility

  THE MANUFACTURER BECAME AWARE OF A STUDY FROM (B)(6) HOSPITAL, (B)(6). THE TITLE OF THIS REPORT IS ¿OPERATIVE TREATMENTS COMPARED WITH NONOPERATIVE TREATMENT OF DISPLACED MIDSHAFT CLAVICULAR FRACTURES¿ WHICH IS ASSOCIATED WITH THE STRYKER APEX SYSTEM AND PLATING SYSTEM. WITHIN THAT PUBLICATION, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED WHICH OCCURRED BETWEEN MARCH 2012 AND MAY 2015. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE LOT OR PATIENT INFORMATION FROM THE REPORT, A REVIEW OF THE COMPLAINT HANDLING DATABASE, HOWEVER, REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED BY THE HOSPITAL OR BY THE AUTHOR OF THE PUBLICATION, THEREFORE 28 COMPLAINTS WERE INITIATED RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES HARDWARE IRRITATION. 3 OUT OF 3 CASES.

  Patient problems: Irritation

  MAUDE report 8947893 ↗
• InjuryAug 29, 2019Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER BECAME AWARE OF A STUDY FROM (B)(6). THE TITLE OF THIS REPORT IS ¿OPERATIVE TREATMENTS COMPARED WITH NONOPERATIVE TREATMENT OF DISPLACED MIDSHAFT CLAVICULAR FRACTURES¿ WHICH IS ASSOCIATED WITH THE STRYKER APEX SYSTEM AND PLATING SYSTEM. WITHIN THAT PUBLICATION, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED WHICH OCCURRED BETWEEN MARCH 2012 AND MAY 2015. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE LOT OR PATIENT INFORMATION FROM THE REPORT, A REVIEW OF THE COMPLAINT HANDLING DATABASE, HOWEVER, REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED BY THE HOSPITAL OR BY THE AUTHOR OF THE PUBLICATION, THEREFORE 28 COMPLAINTS WERE INITIATED RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES HARDWARE IRRITATION. 3 OUT OF 3 CASES.

  Patient problems: Irritation

  MAUDE report 8947892 ↗
• InjuryAug 29, 2019Patient-Device Incompatibility

  THE MANUFACTURER BECAME AWARE OF A STUDY FROM (B)(6). THE TITLE OF THIS REPORT IS ¿OPERATIVE TREATMENTS COMPARED WITH NONOPERATIVE TREATMENT OF DISPLACED MIDSHAFT CLAVICULAR FRACTURES¿ WHICH IS ASSOCIATED WITH THE STRYKER APEX SYSTEM AND PLATING SYSTEM. WITHIN THAT PUBLICATION, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED WHICH OCCURRED BETWEEN MARCH 2012 AND MAY 2015. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE LOT OR PATIENT INFORMATION FROM THE REPORT, A REVIEW OF THE COMPLAINT HANDLING DATABASE, HOWEVER, REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED BY THE HOSPITAL OR BY THE AUTHOR OF THE PUBLICATION, THEREFORE 28 COMPLAINTS WERE INITIATED RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES HARDWARE IRRITATION. 3 OUT OF 3 CASES.

  Patient problems: Irritation

  MAUDE report 8947788 ↗
• InjuryAug 29, 2019Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER BECAME AWARE OF A STUDY FROM QINGHAI PROVINCIAL PEOPLE'S HOSPITAL, CHINA. THE TITLE OF THIS REPORT IS ¿OPERATIVE TREATMENTS COMPARED WITH NONOPERATIVE TREATMENT OF DISPLACED MIDSHAFT CLAVICULAR FRACTURES¿ WHICH IS ASSOCIATED WITH THE STRYKER APEX SYSTEM AND PLATING SYSTEM. WITHIN THAT PUBLICATION, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED WHICH OCCURRED BETWEEN MARCH 2012 AND MAY 2015. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE LOT OR PATIENT INFORMATION FROM THE REPORT, A REVIEW OF THE COMPLAINT HANDLING DATABASE, HOWEVER, REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED BY THE HOSPITAL OR BY THE AUTHOR OF THE PUBLICATION, THEREFORE 28 COMPLAINTS WERE INITIATED RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES HARDWARE IRRITATION. 1 OUT OF 3 CASES.

  Patient problems: Irritation

  MAUDE report 8947787 ↗
• InjuryAug 29, 2019Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER BECAME AWARE OF A STUDY FROM (B)(6). THE TITLE OF THIS REPORT IS ¿OPERATIVE TREATMENTS COMPARED WITH NONOPERATIVE TREATMENT OF DISPLACED MIDSHAFT CLAVICULAR FRACTURES¿ WHICH IS ASSOCIATED WITH THE STRYKER APEX SYSTEM AND PLATING SYSTEM. WITHIN THAT PUBLICATION, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED WHICH OCCURRED BETWEEN MARCH 2012 AND MAY 2015. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE LOT OR PATIENT INFORMATION FROM THE REPORT, A REVIEW OF THE COMPLAINT HANDLING DATABASE, HOWEVER, REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED BY THE HOSPITAL OR BY THE AUTHOR OF THE PUBLICATION, THEREFORE 28 COMPLAINTS WERE INITIATED RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES HARDWARE IRRITATION. 1 OUT OF 3 CASES.

  Patient problems: Irritation

  MAUDE report 8947786 ↗
• InjuryAug 29, 2019Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER BECAME AWARE OF A STUDY FROM (B)(6) HOSPITAL, (B)(6). THE TITLE OF THIS REPORT IS ¿OPERATIVE TREATMENTS COMPARED WITH NONOPERATIVE TREATMENT OF DISPLACED MIDSHAFT CLAVICULAR FRACTURES¿ WHICH IS ASSOCIATED WITH THE STRYKER APEX SYSTEM AND PLATING SYSTEM. WITHIN THAT PUBLICATION, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED WHICH OCCURRED BETWEEN MARCH 2012 AND MAY 2015. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE LOT OR PATIENT INFORMATION FROM THE REPORT, A REVIEW OF THE COMPLAINT HANDLING DATABASE, HOWEVER, REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED BY THE HOSPITAL OR BY THE AUTHOR OF THE PUBLICATION, THEREFORE 28 COMPLAINTS WERE INITIATED RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES HARDWARE IRRITATION. 1 OUT OF 3 CASES.

  Patient problems: Irritation

  MAUDE report 8947785 ↗
• InjuryAug 29, 2019Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER BECAME AWARE OF A STUDY FROM (B)(6). THE TITLE OF THIS REPORT IS ¿OPERATIVE TREATMENTS COMPARED WITH NONOPERATIVE TREATMENT OF DISPLACED MIDSHAFT CLAVICULAR FRACTURES¿ WHICH IS ASSOCIATED WITH THE STRYKER APEX SYSTEM AND PLATING SYSTEM. WITHIN THAT PUBLICATION, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED WHICH OCCURRED BETWEEN MARCH 2012 AND MAY 2015. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE LOT OR PATIENT INFORMATION FROM THE REPORT, A REVIEW OF THE COMPLAINT HANDLING DATABASE, HOWEVER, REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED BY THE HOSPITAL OR BY THE AUTHOR OF THE PUBLICATION, THEREFORE 28 COMPLAINTS WERE INITIATED RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES COMPLEX REGIONAL PAIN SYNDROME.

  Patient problems: Pain

  MAUDE report 8947617 ↗
• InjuryAug 29, 2019Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER BECAME AWARE OF A STUDY FROM (B)(6). THE TITLE OF THIS REPORT IS ¿OPERATIVE TREATMENTS COMPARED WITH NONOPERATIVE TREATMENT OF DISPLACED MIDSHAFT CLAVICULAR FRACTURES¿ WHICH IS ASSOCIATED WITH THE STRYKER APEX SYSTEM AND PLATING SYSTEM. WITHIN THAT PUBLICATION, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED WHICH OCCURRED BETWEEN MARCH 2012 AND MAY 2015. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE LOT OR PATIENT INFORMATION FROM THE REPORT, A REVIEW OF THE COMPLAINT HANDLING DATABASE, HOWEVER, REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED BY THE HOSPITAL OR BY THE AUTHOR OF THE PUBLICATION, THEREFORE 28 COMPLAINTS WERE INITIATED RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES COMPLEX REGIONAL PAIN SYNDROME.

  Patient problems: Pain

  MAUDE report 8947615 ↗
• InjuryAug 29, 2019Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER BECAME AWARE OF A STUDY FROM (B)(6). THE TITLE OF THIS REPORT IS ¿OPERATIVE TREATMENTS COMPARED WITH NONOPERATIVE TREATMENT OF DISPLACED MIDSHAFT CLAVICULAR FRACTURES¿ WHICH IS ASSOCIATED WITH THE STRYKER APEX SYSTEM AND PLATING SYSTEM. WITHIN THAT PUBLICATION, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED WHICH OCCURRED BETWEEN MARCH 2012 AND MAY 2015. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE LOT OR PATIENT INFORMATION FROM THE REPORT, A REVIEW OF THE COMPLAINT HANDLING DATABASE, HOWEVER, REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED BY THE HOSPITAL OR BY THE AUTHOR OF THE PUBLICATION, THEREFORE 28 COMPLAINTS WERE INITIATED RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES COMPLEX REGIONAL PAIN SYNDROME.

  Patient problems: Pain

  MAUDE report 8947612 ↗
• InjuryAug 29, 2019Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER BECAME AWARE OF A STUDY FROM (B)(6). THE TITLE OF THIS REPORT IS ¿OPERATIVE TREATMENTS COMPARED WITH NONOPERATIVE TREATMENT OF DISPLACED MIDSHAFT CLAVICULAR FRACTURES¿ WHICH IS ASSOCIATED WITH THE STRYKER APEX SYSTEM AND PLATING SYSTEM. WITHIN THAT PUBLICATION, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED WHICH OCCURRED BETWEEN MARCH 2012 AND MAY 2015. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE LOT OR PATIENT INFORMATION FROM THE REPORT, A REVIEW OF THE COMPLAINT HANDLING DATABASE, HOWEVER, REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED BY THE HOSPITAL OR BY THE AUTHOR OF THE PUBLICATION, THEREFORE 28 COMPLAINTS WERE INITIATED RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES PIN INFECTION. 4 OUT OF 4 CASES. THE REPORT STATES, ¿FOR THE EXTERNAL FIXATION GROUP, AS THE BIGGEST COMPLICATION, PIN INFECTION WAS TREATED WITH ANTIBIOTICS AND LOCAL WOUND CARE. ALL PATIENTS WERE EVENTUALLY CURED.¿

  Patient problems: Unspecified Infection

  MAUDE report 8947509 ↗
• InjuryAug 29, 2019Patient-Device Incompatibility

  THE MANUFACTURER BECAME AWARE OF A STUDY FROM (B)(6). THE TITLE OF THIS REPORT IS ¿OPERATIVE TREATMENTS COMPARED WITH NONOPERATIVE TREATMENT OF DISPLACED MIDSHAFT CLAVICULAR FRACTURES¿ WHICH IS ASSOCIATED WITH THE STRYKER APEX SYSTEM AND PLATING SYSTEM. WITHIN THAT PUBLICATION, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED WHICH OCCURRED BETWEEN MARCH 2012 AND MAY 2015. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE LOT OR PATIENT INFORMATION FROM THE REPORT, A REVIEW OF THE COMPLAINT HANDLING DATABASE, HOWEVER, REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED BY THE HOSPITAL OR BY THE AUTHOR OF THE PUBLICATION, THEREFORE 28 COMPLAINTS WERE INITIATED RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES PIN INFECTION. 4 OUT OF 4 CASES. THE REPORT STATES, ¿FOR THE EXTERNAL FIXATION GROUP, AS THE BIGGEST COMPLICATION, PIN INFECTION WAS TREATED WITH ANTIBIOTICS AND LOCAL WOUND CARE. ALL PATIENTS WERE EVENTUALLY CURED.¿

  Patient problems: Bone Fracture(s); Unspecified Infection

  MAUDE report 8947507 ↗
• InjuryAug 29, 2019Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER BECAME AWARE OF A STUDY FROM (B)(6). THE TITLE OF THIS REPORT IS ¿OPERATIVE TREATMENTS COMPARED WITH NONOPERATIVE TREATMENT OF DISPLACED MIDSHAFT CLAVICULAR FRACTURES¿ WHICH IS ASSOCIATED WITH THE STRYKER APEX SYSTEM AND PLATING SYSTEM. WITHIN THAT PUBLICATION, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED WHICH OCCURRED BETWEEN MARCH 2012 AND MAY 2015. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE LOT OR PATIENT INFORMATION FROM THE REPORT, A REVIEW OF THE COMPLAINT HANDLING DATABASE, HOWEVER, REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED BY THE HOSPITAL OR BY THE AUTHOR OF THE PUBLICATION, THEREFORE 28 COMPLAINTS WERE INITIATED RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES PIN INFECTION. 4 OUT OF 4 CASES. THE REPORT STATES, ¿FOR THE EXTERNAL FIXATION GROUP, AS THE BIGGEST COMPLICATION, PIN INFECTION WAS TREATED WITH ANTIBIOTICS AND LOCAL WOUND CARE. ALL PATIENTS WERE EVENTUALLY CURED.¿

  Patient problems: Unspecified Infection

  MAUDE report 8947505 ↗
• InjuryAug 29, 2019Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER BECAME AWARE OF A STUDY FROM (B)(6) HOSPITAL, (B)(6). THE TITLE OF THIS REPORT IS ¿OPERATIVE TREATMENTS COMPARED WITH NONOPERATIVE TREATMENT OF DISPLACED MIDSHAFT CLAVICULAR FRACTURES¿ WHICH IS ASSOCIATED WITH THE STRYKER APEX SYSTEM AND PLATING SYSTEM. WITHIN THAT PUBLICATION, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED WHICH OCCURRED BETWEEN (B)(6) 2012 AND (B)(6) 2015. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE LOT OR PATIENT INFORMATION FROM THE REPORT, A REVIEW OF THE COMPLAINT HANDLING DATABASE, HOWEVER, REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED BY THE HOSPITAL OR BY THE AUTHOR OF THE PUBLICATION, THEREFORE 28 COMPLAINTS WERE INITIATED RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES COMPLEX REGIONAL PAIN SYNDROME.

  Patient problems: Pain

  MAUDE report 8947503 ↗
• InjuryAug 29, 2019Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER BECAME AWARE OF A STUDY FROM (B)(6). THE TITLE OF THIS REPORT IS ¿OPERATIVE TREATMENTS COMPARED WITH NONOPERATIVE TREATMENT OF DISPLACED MIDSHAFT CLAVICULAR FRACTURES¿ WHICH IS ASSOCIATED WITH THE STRYKER APEX SYSTEM AND PLATING SYSTEM. WITHIN THAT PUBLICATION, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED WHICH OCCURRED BETWEEN MARCH 2012 AND MAY 2015. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE LOT OR PATIENT INFORMATION FROM THE REPORT, A REVIEW OF THE COMPLAINT HANDLING DATABASE, HOWEVER, REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED BY THE HOSPITAL OR BY THE AUTHOR OF THE PUBLICATION, THEREFORE 28 COMPLAINTS WERE INITIATED RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES PIN INFECTION. 4 OUT OF 4 CASES. THE REPORT STATES, ¿FOR THE EXTERNAL FIXATION GROUP, AS THE BIGGEST COMPLICATION, PIN INFECTION WAS TREATED WITH ANTIBIOTICS AND LOCAL WOUND CARE. ALL PATIENTS WERE EVENTUALLY CURED.¿

  Patient problems: Unspecified Infection

  MAUDE report 8947502 ↗
• InjuryAug 29, 2019Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER BECAME AWARE OF A STUDY FROM (B)(6). THE TITLE OF THIS REPORT IS ¿OPERATIVE TREATMENTS COMPARED WITH NONOPERATIVE TREATMENT OF DISPLACED MIDSHAFT CLAVICULAR FRACTURES¿ WHICH IS ASSOCIATED WITH THE STRYKER APEX SYSTEM AND PLATING SYSTEM. WITHIN THAT PUBLICATION, POST-OPERATIVE COMPLICATIONS/ADVERSE EVENTS WERE REPORTED WHICH OCCURRED BETWEEN (B)(6) 2012 AND (B)(6) 2015. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE LOT OR PATIENT INFORMATION FROM THE REPORT, A REVIEW OF THE COMPLAINT HANDLING DATABASE, HOWEVER, REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED BY THE HOSPITAL OR BY THE AUTHOR OF THE PUBLICATION, THEREFORE 28 COMPLAINTS WERE INITIATED RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES PIN INFECTION. 2 OUT OF 4 CASES. THE REPORT STATES, ¿FOR THE EXTERNAL FIXATION GROUP, AS THE BIGGEST COMPLICATION, PIN INFECTION WAS TREATED WITH ANTIBIOTICS AND LOCAL WOUND CARE. ALL PATIENTS WERE EVENTUALLY CURED.¿

  Patient problems: Unspecified Infection

  MAUDE report 8945573 ↗
• InjuryAug 29, 2019Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER BECAME AWARE OF A STUDY FROM (B)(6). THE TITLE OF THIS REPORT IS ¿OPERATIVE TREATMENTS COMPARED WITH NONOPERATIVE TREATMENT OF DISPLACED MIDSHAFT CLAVICULAR FRACTURES¿ WHICH IS ASSOCIATED WITH THE STRYKER APEX SYSTEM AND PLATING SYSTEM. WITHIN THAT PUBLICATION, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED WHICH OCCURRED BETWEEN MARCH 2012 AND MAY 2015. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE LOT OR PATIENT INFORMATION FROM THE REPORT, A REVIEW OF THE COMPLAINT HANDLING DATABASE, HOWEVER, REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED BY THE HOSPITAL OR BY THE AUTHOR OF THE PUBLICATION, THEREFORE 28 COMPLAINTS WERE INITIATED RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES PIN INFECTION. 2 OUT OF 4 CASES. THE REPORT STATES, ¿FOR THE EXTERNAL FIXATION GROUP, AS THE BIGGEST COMPLICATION, PIN INFECTION WAS TREATED WITH ANTIBIOTICS AND LOCAL WOUND CARE. ALL PATIENTS WERE EVENTUALLY CURED.¿

  Patient problems: Unspecified Infection

  MAUDE report 8945563 ↗
• InjuryAug 29, 2019Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER BECAME AWARE OF A STUDY FROM (B)(6) HOSPITAL, (B)(6). THE TITLE OF THIS REPORT IS ¿OPERATIVE TREATMENTS COMPARED WITH NONOPERATIVE TREATMENT OF DISPLACED MIDSHAFT CLAVICULAR FRACTURES¿ WHICH IS ASSOCIATED WITH THE STRYKER APEX SYSTEM AND PLATING SYSTEM. WITHIN THAT PUBLICATION, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED WHICH OCCURRED BETWEEN MARCH 2012 AND MAY 2015. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE LOT OR PATIENT INFORMATION FROM THE REPORT, A REVIEW OF THE COMPLAINT HANDLING DATABASE, HOWEVER, REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED BY THE HOSPITAL OR BY THE AUTHOR OF THE PUBLICATION, THEREFORE 28 COMPLAINTS WERE INITIATED RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES PIN INFECTION. 2 OUT OF 4 CASES. THE REPORT STATES, ¿FOR THE EXTERNAL FIXATION GROUP, AS THE BIGGEST COMPLICATION, PIN INFECTION WAS TREATED WITH ANTIBIOTICS AND LOCAL WOUND CARE. ALL PATIENTS WERE EVENTUALLY CURED.¿

  Patient problems: Unspecified Infection

  MAUDE report 8945344 ↗
• InjuryAug 29, 2019Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER BECAME AWARE OF A STUDY FROM (B)(6) HOSPITAL, (B)(6). THE TITLE OF THIS REPORT IS ¿OPERATIVE TREATMENTS COMPARED WITH NONOPERATIVE TREATMENT OF DISPLACED MIDSHAFT CLAVICULAR FRACTURES¿ WHICH IS ASSOCIATED WITH THE STRYKER APEX SYSTEM AND PLATING SYSTEM. WITHIN THAT PUBLICATION, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED WHICH OCCURRED BETWEEN MARCH 2012 AND MAY 2015. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE LOT OR PATIENT INFORMATION FROM THE REPORT, A REVIEW OF THE COMPLAINT HANDLING DATABASE, HOWEVER, REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED BY THE HOSPITAL OR BY THE AUTHOR OF THE PUBLICATION, THEREFORE 28 COMPLAINTS WERE INITIATED RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES PIN INFECTION. 3 OUT OF 4 CASES. THE REPORT STATES, ¿FOR THE EXTERNAL FIXATION GROUP, AS THE BIGGEST COMPLICATION, PIN INFECTION WAS TREATED WITH ANTIBIOTICS AND LOCAL WOUND CARE. ALL PATIENTS WERE EVENTUALLY CURED.¿

  Patient problems: Unspecified Infection

  MAUDE report 8945342 ↗
• InjuryAug 29, 2019Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER BECAME AWARE OF A STUDY FROM (B)(6) HOSPITAL, (B)(6). THE TITLE OF THIS REPORT IS ¿OPERATIVE TREATMENTS COMPARED WITH NONOPERATIVE TREATMENT OF DISPLACED MIDSHAFT CLAVICULAR FRACTURES¿ WHICH IS ASSOCIATED WITH THE STRYKER APEX SYSTEM AND PLATING SYSTEM. WITHIN THAT PUBLICATION, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED WHICH OCCURRED BETWEEN MARCH 2012 AND MAY 2015. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE LOT OR PATIENT INFORMATION FROM THE REPORT, A REVIEW OF THE COMPLAINT HANDLING DATABASE, HOWEVER, REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED BY THE HOSPITAL OR BY THE AUTHOR OF THE PUBLICATION, THEREFORE 28 COMPLAINTS WERE INITIATED RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES PIN INFECTION. 2 OUT OF 4 CASES. THE REPORT STATES, ¿FOR THE EXTERNAL FIXATION GROUP, AS THE BIGGEST COMPLICATION, PIN INFECTION WAS TREATED WITH ANTIBIOTICS AND LOCAL WOUND CARE. ALL PATIENTS WERE EVENTUALLY CURED.¿

  Patient problems: Unspecified Infection

  MAUDE report 8945339 ↗