NA 212.104Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982151780), received between Mar 21, 2018 and Nov 11, 2022 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (2 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryNov 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION DUE TO RIGHT MEDIAL MALLEOLUS FRACTURE. IN RADIOLOGY (B)(6) 2021 STABLE FIXATION RIGHT SYNDESMOSIS AND RIGHT FIBULA. MEDIAL MALLEOLAR FRAGMENT WITH DISPLACEMENT. THIS REPORT IS FOR ONE (1)3.5 LCKNG SCREW SLF-TPNG W/SD(TM) REC 16 THIS IS REPORT 2 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: Bone Fracture(s); Physical Asymmetry

  MAUDE report 15779041 ↗
• MalfunctionJul 15, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED ON AN UNKNOWN DATE IT WAS DISCOVERED THE PACKAGING THAT SHOULD CONTAIN A LOCKING SCREW WAS EMPTY. IT WAS NOTED THE BAG WAS SEALED. THIS REPORT IS FOR A LOCKING SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12172678 ↗
• InjuryJan 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNKNOWN SURGERY, LOCKING COMPRESSION PLATE, CORTEX SCREWS, AND LOCKING SCREWS WERE TAKEN OUT DUE TO PATIENT PAIN. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. CONCOMITANT DEVICES REPORTED: 2.7MM CORTEX SCREW SELF-TAPPING 16MM (PART NUMBER 202.816, LOT UNKNOWN, QUANTITY 1), 3.5MM CORTEX SCREW SELF-TAPPING 16MM (PART NUMBER 204.816, LOT UNKNOWN, QUANTITY 1), 2.7MM/3.5MM VA-LCP LAT ANT CLAVICLE PLATE/11H/113MM (PART NUMBER 02.112.048, LOT UNKNOWN, QUANTITY 1), 3.5MM CORTEX SCREW SELF-TAPPING 14MM (PART NUMBER 204.814, LOT UNKNOWN, QUANTITY 1) 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM (PART NUMBER 02.211.016, LOT UNKNOWN, QUANTITY 1), 3.5MM CORTEX SCREW SELF-TAPPING 16MM (PART NUMBER 204.816, LOT UNKNOWN, QUANTITY 1) 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM (PART NUMBER 02.211.016, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 16MM. THIS IS REPORT 4 OF 8 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 11163216 ↗
• MalfunctionMay 1, 2020Incomplete or Missing Packaging; Incomplete or Missing Packaging

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE FACILITY TOOK A PICTURE OF THE IMPLANTS SHIPPED TO SHOW THE ORDER CONFIRMATION, HOWEVER, THE IMPLANTS WERE NOT INSIDE THE BAG AND THE BAG WAS NOT DAMAGED. THE FACILITY PLACED A STANDARD ORDER AND SIX (6) ITEMS WERE SHIPPED WITH A QUANTITY OF ONE (1) ON EACH ITEM AND NONE OF THOSE ITEMS WERE IN THE BAG. THERE WAS NO PATIENT NOR PROCEDURE INVOLVEMENT. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 16MM. THIS REPORT IS 2 OF 3 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10018795 ↗
• MalfunctionMar 20, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, A PLASTIC ENVELOPE/SLEEVE WITH A LOCKING SCREW WAS EMPTY. IT WAS DISCOVERED THAT ENVELOPE WAS EMPTY WHEN PACKAGING WAS OPENED FOR SET RESTOCKING. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 16MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8435785 ↗
• MalfunctionMay 21, 2018Failure To Adhere Or Bond; Failure To Adhere Or Bond

  IT WAS REPORTED THAT ON (B)(6) 2018 DURING AN UNKNOWN PROCEDURE, AN 8-HOLE 1/3 TUBULAR PLATE WAS PLACED ON THE PATIENT'S DISTAL FIBULA. AFTER DRILLING THROUGH THE DRILL GUIDE, THE LOCKING SCREW WOULD NOT LOCK INTO THE PLATE. THE SURGEON TRIED ANOTHER SCREW AND THE SCREW LOCKED IN. THE PATIENT OUTCOME WAS STABLE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS A FOUR (4) MINUTE SURGICAL DELAY AND WAS NO PATIENT CONSEQUENCE REPORTED. NO OTHER ADDITIONAL INFORMATION AVAILABLE. CONCOMITANT DEVICE: UNKNOWN DRILL GUIDE (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7531330 ↗
• InjuryApr 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER QUALITY UNIT RECEIVED A USER FACILITY REPORT FORWARDED FROM (B)(6) HOSPITAL; THIS REPORT IS AGAINST USER FACILITY MEDWATCH REPORT # (B)(4). ONLY ADDITIONAL AND/OR CORRECTED INFORMATION WILL BE CONTAINED IN THIS REPORT. IT WAS REPORTED PATIENT UNDERWENT A PROCEDURE IN WHICH THE 2.7MM/3.5MM LOCKING COMPRESSION PLATE (LCP) POSTEROLATERAL DISTAL FIBULA PLATE AND THIRTEEN (13) SCREWS FOR A CLAVICLE FRACTURE ON (B)(6) 2017. ON UNKNOWN DATE PATIENT DEVELOPED AN INFECTION AT THE IMPLANT SITE. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE SURGEON REMOVED ELEVEN (11) OF THE SCREWS AND THE PLATE. IT IS UNKNOWN WHY TWO (2) OF THE SCREWS REMAIN IMPLANTED. SURGERY WAS COMPLETED. PATIENT STATUS REPORTED AS OKAY. THIS REPORT IS FOR ONE (1) 3.5MM LOCKING SCREW 16MM. THIS IS REPORT 10 OF 10 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7434765 ↗
• InjuryMar 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANKLE REVISION ON (B)(6) 2018, DUE TO A BROKEN KRSCHNER WIRE (K-WIRE) IN MEDIAL MALLEOLUS AND INSTABILITY. THE HARDWARE WAS ORIGINALLY PLACED ON (B)(6) 2017. DURING THE REVISION, THE SURGEON REMOVED ONE (1) UNKNOWN 4.0 CANCELLOUS SCREW AND THE BROKEN K-WIRE FROM THE MEDIAL MALLEOLUS. ALL K-WIRE FRAGMENTS WERE REMOVED WITHOUT ANY ADDITIONAL MEDICAL INTERVENTION BEING REQUIRED. THE 4.0 MM CANCELLOUS SCREW WAS REPLACED WITH A 3.5 MM SYNDESMOSIS CORTICAL SCREW TO MAKE THE CONSTRUCT MORE STABLE. A SECOND SCREW; A 3.5 MM LOCKING SCREW THAT WAS PREVIOUSLY IMPLANTED THROUGH A PLATE ON THE FIBULA WAS REPLACED THROUGH THE MEDIAL MALLEOLUS WITH A LONGER SYNDESMOSIS CORTEX SCREW AS THE SURGEON HAD NOT ADDRESSED THE SYNDESMOSIS IN THE ORIGINAL SURGERY AND THE CONSTRUCT WAS UNSTABLE. THERE WAS REPORTEDLY NO CONSEQUENCE TO THE PATIENT, THE PATIENT HAD NO ADDITIONAL CLINICAL FINDINGS AND NO KNOWN COMORBIDITIES. THE PATIENT WAS REPORTED TO BE STABLE AT THE END OF THE PROCEDURE. CONCOMITANT DEVICES REPORTED: LOCKING PLATE: (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 3.5 MM LOCKING SCREW 16 MM. THIS IS REPORT 1 OF 3 FOR

  Patient problems: No Code Available

  MAUDE report 7356928 ↗

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,