NA 212.109Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982151834), received between Nov 30, 2017 and Jul 7, 2022 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K000684, K072095); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 7, 2022Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN FRANCE AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022 THERE WAS LACK OF LOCKING OF 2.7 MM LOCKING SCREWS IN TWO (2) LOW COMPRESSION PLATE (LCP) ELBOW PLATES WITH A DYNAMOMETRIC SCREWDRIVER INTRAOPERATIVELY. SEVERAL SCREWS BENT AND THERE WERE TWO (2) EDGES ON ONE SIDE. THE PATIENT WAS IMMOBILIZED FOR TEN (10) DAYS AND X-RAYS WERE TAKEN. A SURGICAL REVISION IS PLANNED TO REMOVE EVERYTHING BUT HAS NOT YET BEEN COMPLETED. IMPLANTS ARE STILL CURRENTLY IMPLANTED IN THE PATIENT. THIS IS REPORT 3 OF 12 FOR (B)(4). THIS REPORT IS FOR A LOCKING SCREW.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Tissue Injury

  MAUDE report 14949914 ↗
• MalfunctionMar 5, 2020Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE FACILITY ORDERED A LOCKING SCREW SELF TAPPING WITH STARDRIVE RECESS HOWEVER, THE PACKAGE WAS EMPTY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A 3.5MM LOCKING SCREW 26MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9794879 ↗
• InjuryNov 30, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ORIGINAL SURGERY TO TREAT A LEFT PROXIMAL HUMERUS FRACTURE WAS PERFORMED ON (B)(6) 2017. THE PATIENT WAS IMPLANTED WITH SIXTEEN (16) SYNTHES DEVICES WHICH INCLUDE TWELVE (12) LOCKING SCREWS, THREE (3) CORTEX SCREWS AND ONE (1) PLATE. THE PATIENT RETURNED ON AN UNKNOWN DATE FOR POST-OPERATIVE X-RAYS. THE X-RAYS REVEALED NON-UNION AS THE FRACTURE DID NOT HEAL AS EXPECTED. IT WAS ALSO REPORTED THAT THE PATIENT HAD FALLEN MULTIPLE TIMES POST-OPERATIVELY AND WAS NON-COMPLAINT WITH POST-OPERATIVE CARE. TO ADDRESS THE NON-UNION, SURGEON WILL BE PERFORMING A REVISION FOR HARDWARE REMOVAL ON (B)(6) 2017. IT HAS BEEN DECIDED THAT ALL OF THE 16 IMPLANTED DEVICES WILL BE REMOVED. PATIENT WILL BE REVISED TO A DIFFERENT TREATMENT PLAN AND NO NEW DEVICES WILL BE IMPLANTED; IT IS UNKNOW IF THAT PROCEDURE OCCURRED AS PLANNED. THERE WAS NO REPORTED PRODUCT PROBLEM AND PER THE X-RAYS, THE DEVICES APPEARED TO BE INTACT. THIS IS REPORT 12 OF 16 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7071294 ↗
• InjuryNov 30, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ORIGINAL SURGERY TO TREAT A LEFT PROXIMAL HUMERUS FRACTURE WAS PERFORMED ON (B)(6) 2017. THE PATIENT WAS IMPLANTED WITH SIXTEEN (16) SYNTHES DEVICES WHICH INCLUDE TWELVE (12) LOCKING SCREWS, THREE (3) CORTEX SCREWS AND ONE (1) PLATE. THE PATIENT RETURNED ON AN UNKNOWN DATE FOR POST-OPERATIVE X-RAYS. THE X-RAYS REVEALED NON-UNION AS THE FRACTURE DID NOT HEAL AS EXPECTED. IT WAS ALSO REPORTED THAT THE PATIENT HAD FALLEN MULTIPLE TIMES POST-OPERATIVELY AND WAS NON-COMPLAINT WITH POST-OPERATIVE CARE. TO ADDRESS THE NON-UNION, SURGEON WILL BE PERFORMING A REVISION FOR HARDWARE REMOVAL ON (B)(6) 2017. IT HAS BEEN DECIDED THAT ALL OF THE 16 IMPLANTED DEVICES WILL BE REMOVED. PATIENT WILL BE REVISED TO A DIFFERENT TREATMENT PLAN AND NO NEW DEVICES WILL BE IMPLANTED; IT IS UNKNOWN IF THAT PROCEDURE OCCURRED AS PLANNED. THERE WAS NO REPORTED PRODUCT PROBLEM AND PER THE X-RAYS, THE DEVICES APPEARED TO BE INTACT. THIS IS REPORT 13 OF 16 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7071161 ↗
• InjuryNov 30, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ORIGINAL SURGERY TO TREAT A LEFT PROXIMAL HUMERUS FRACTURE WAS PERFORMED ON (B)(6) 2017. THE PATIENT WAS IMPLANTED WITH SIXTEEN (16) SYNTHES DEVICES WHICH INCLUDE TWELVE (12) LOCKING SCREWS, THREE (3) CORTEX SCREWS AND ONE (1) PLATE. THE PATIENT RETURNED ON AN UNKNOWN DATE FOR POST-OPERATIVE X-RAYS. THE X-RAYS REVEALED NON-UNION AS THE FRACTURE DID NOT HEAL AS EXPECTED. IT WAS ALSO REPORTED THAT THE PATIENT HAD FALLEN MULTIPLE TIMES POST-OPERATIVELY AND WAS NON-COMPLAINT WITH POST-OPERATIVE CARE. TO ADDRESS THE NON-UNION, SURGEON WILL BE PERFORMING A REVISION FOR HARDWARE REMOVAL ON (B)(6) 2017. IT HAS BEEN DECIDED THAT ALL OF THE 16 IMPLANTED DEVICES WILL BE REMOVED. PATIENT WILL BE REVISED TO A DIFFERENT TREATMENT PLAN AND NO NEW DEVICES WILL BE IMPLANTED; IT IS UNKNOWN IF THAT PROCEDURE OCCURRED AS PLANNED. THERE WAS NO REPORTED PRODUCT PROBLEM AND PER THE X-RAYS, THE DEVICES APPEARED TO BE INTACT. THIS IS REPORT 4 OF 16 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7070708 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K000684, K072095. One submission often covers many models, so check the product and lot details in each record.

• Z-1800-2015 · May 13, 2015 · Terminated
  3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the Cannulated Screws are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle,