NA 02.127.160Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982043344), received between Jun 8, 2018 and Apr 27, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Failure To Adhere Or Bond” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD SURGERY ON (B)(6) 2022 TO IMPLANT THE DEVICE. ON (B)(6) 2023, IT APPEARED THAT THE PATIENT HAD DEVELOPED A REACTION ISSUE WITH THE TITANIUM IN HIS LOWER LEG. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 5 OF 11 FOR (B)(4). THIS REPORT INVOLVES ONE (1) 3.5 VA LCKNG SCR SLF-TPNG/SD/60.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 16823908 ↗
• InjuryJun 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A SCREW REMOVAL DUE TO PAIN. THERE WERE THREE (3) VARIABLE ANGLE (VA) LOCKING SCREWS THAT WERE REMOVED. THE IMPLANTED SCREWS WERE TOO LONG, WHICH CAUSED PAIN TO THE PATIENT. CONCOMITANT DEVICE REPORTED: PLATE (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1), SCREW (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN), 3.5MM VARIABLE ANGLE LOCKING SCREW/SLF-TPNG/STRDRV/70MM (PART NUMBER 02.127.170, LOT UNKNOWN, QUANTITY 1), 3.5MM VARIABLE ANGLE LOCKING SCREW/SLF-TPNG/STRDRV/75MM (PART NUMBER 02.127.175, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 3.5MM VARIABLE ANGLE LOCKING SCREW/SLF-TPNG/STRDRV/60MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 10128093 ↗
• MalfunctionJun 8, 2018Failure To Adhere Or Bond; Failure To Adhere Or Bond

  IT WAS REPORTED THAT ON (B)(6) 2018, DURING A TIBIA PLATEAU FRACTURE REPAIR, A LOCKING SCREW WENT THROUGH A VARIABLE ANGLE - LOCKING COMPRESSION PROXIMAL TIBIA PLATE (LCP). INITIALLY, THE SURGEON USED A POWER DRIVER WITH TORQUE LIMITER TO IMPLANT SIX (6) LOCKING SCREWS INTO THE PLATE. THE SURGEON THEN USED STARDRIVE SCREWDRIVER FROM A LOCKING SMALL FRAGMENT SET TO FINAL TIGHTEN THE SCREWS. ON (B)(6) 2018, INTRA-OPERATIVELY, X-RAY WAS DONE AND IT CONFIRMED THAT ONE OF THE SCREWS HAD GONE THROUGH THE PLATE. THE SURGEON THEN BACKED THE SCREW OUT AND DISCARDED IT. THE SCREW WAS INTACT, BUT THE HOLE IN THE PLATE HAD STRIPPED AFTER THE SURGEON TIGHTENED WITHOUT TORQUE LIMITER. INSTEAD OF A CLOVER SHAPE, IT APPEARED AS A CIRCLE. THAT HOLE WAS LEFT EMPTY. THERE WERE ALSO SUPPLEMENTAL SCREWS THAT WERE USED TO PROVIDE A TEMPORARY FIXATION ON THE SIDE OF THE TIBIA BUT THEY WERE REMOVED AS THEY WERE NEVER INTENDED ON BEING IMPLANTED. THERE WAS AN APPROXIMATE ONE-MINUTE SURGICAL DELAY TO REMOVE THE SCREW. THE FINAL CONSTRUCT INCLUDED ONE (1) PLATE AND FIVE (5) SCREWS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME WAS STABLE. CONCOMITANT DEVICES REPORTED: TORQUE LIMITING ATTACHMENT (

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7583968 ↗