NA 02.118.534Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982039408), received between Sep 19, 2018 and Jan 26, 2021 — classified as 6 injuries.

1 other recall cover devices cleared under the same FDA submission (K120070, K120717, K120854); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJan 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGERY PROCEDURE WAS PERFORMED TO REMOVE THE IMPLANT. THERE WAS NO SURGICAL DELAY REPORTED. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. IMPLANT DATE (MM/DD/YYYY): (B)(6) 2020. EXPLANT DATE (MM/DD/YYYY): (B)(6) 2020.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11230653 ↗
• InjuryJan 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGERY PROCEDURE WAS PERFORMED TO REMOVE THE IMPLANT. THERE WAS NO SURGICAL DELAY REPORTED. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. IMPLANT DATE (MM/DD/YYYY): (B)(6) 2020. EXPLANT DATE (MM/DD/YYYY): (B)(6) 2020.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11230634 ↗
• InjuryJan 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL EVENT INFORMATION: THE SURGERY PROCEDURE WAS PERFORMED TO REMOVE THE IMPLANT. THERE WAS NO SURGICAL DELAY REPORTED. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. IMPLANT DATE (MM/DD/YYYY): (B)(6) 2020. EXPLANT DATE (MM/DD/YYYY): (B)(6) 2020.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11230584 ↗
• InjuryAug 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION WITH PLATES AND SCREWS AND COMPRESSION DUE TO NONUNION LEFT PROXIMAL ULNA S/P ORIF MONTEGGIA FRACTURE SUBLUXATION. ON (B)(6) 2017, THE PATIENT UNDERWENT AN OPEN REDUCTION AND INTERNAL FIXATION OF THE COMMINUTED LEFT PROXIMAL ULNA AND WHERE A SYNTHES DEVICE WAS IMPLANTED. PRIOR TO THE REPORTED EVENT, THE PATIENT TRIPPED OVER A CURB AND FELL HER ON HER LEFT UPPER EXTREMITY RESULTING TO AN IMMEDIATE SEVERE PAIN. CONCOMITANT DEVICES REPORTED: 2.0 MM CORTEX SCREW SLF-TPNG WITH STARDRIVE RECESS 24 MM (PART NUMBER 201.374.97, LOT UNKNOWN, QUANTITY 1), 3.5 MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 18 MM (PART NUMBER 212.105, LOT UNKNOWN, QUANTITY 1), 2.7 MM/3.5 MM VA-LCP OLECRANON PL 4H/LT/116 MM (PART NUMBER 02.107.304, LOT UNKNOWN, QUANTITY 1), 2.7 MM METAPHYSEAL SCR SLF-TPNG W/T8 STRDRV RECESS/28 MM (PART NUMBER 02.118.528, LOT UNKNOWN, QUANTITY 1), 2.7 MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 20 MM (PART NUMBER 02.211.020, LOT UNKNOWN, QUANTITY 2), 2.7 MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 22 MM (PART NUMBER 02.211.022, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLV

  Patient problems: Bone Fracture(s); No Code Available; Pain

  MAUDE report 10444508 ↗
• InjurySep 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HARDWARE REMOVAL SURGERY DUE TO WOUND BREAKDOWN ON (B)(6) 2018. FOUR (4) SELF TAPPING METAPHYSEAL SCREWS, FOUR (4) VARIABLE ANGLE (VA) SELF TAPPING LOCKING SCREWS, ONE (1) VA LARGE LOCKING CALCANEAL PLATE, ONE (1) SELF TAPPING CORTEX SCREW WERE REMOVED. ONE (1) SELF TAPPING CORTEX SCREW REMAINED IMPLANTED DUE TO UNKNOWN REASON. ORIGINAL IMPLANT DATE IS ON (B)(6) 2018. PATIENT STATUS IS UNKNOWN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY THIS REPORT IS 8 OF 10 FOR (B)(4). THIS COMPLAINT INVOLVES TEN (10) DEVICES.

  Patient problems: Erosion; Not Applicable

  MAUDE report 7891841 ↗
• InjurySep 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HARDWARE REMOVAL SURGERY DUE TO WOUND BREAKDOWN ON (B)(6) 2018. FOUR (4) SELF TAPPING METAPHYSEAL SCREWS, FOUR (4) VARIABLE ANGLE (VA) SELF TAPPING LOCKING SCREWS, ONE (1) VA LARGE LOCKING CALCANEAL PLATE, ONE (1) SELF TAPPING CORTEX SCREW WERE REMOVED. ONE (1) SELF TAPPING CORTEX SCREW REMAINED IMPLANTED DUE TO UNKNOWN REASON. ORIGINAL IMPLANT DATE IS ON (B)(6) 2018. PATIENT STATUS IS UNKNOWN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY THIS REPORT IS 1 OF 10 FOR (B)(4). THIS COMPLAINT INVOLVES TEN (10) DEVICES.

  Patient problems: Erosion; Not Applicable

  MAUDE report 7891817 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K120070, K120717, K120854. One submission often covers many models, so check the product and lot details in each record.

• Z-0124-2016 · Sep 28, 2015 · Terminated
  Synthes 2.7MM/3.5MM VA-LCP Medial Distal Humerus Plates 10H/RT/186mm- Sterile and Synthes 2.7MM/3.5MM VA-LCP Extended Medial Distal Humerus Plates 10H/RT/189mm-Sterile The Synthes