NA 02.211.042Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982053725), received between May 24, 2019 and Oct 30, 2023 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Crack” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 30, 2023Crack; Crack

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN DENMARK AS FOLLOWS: IT WAS REPORTED THAT ON OCTOBER 9, 2023, WHEN THE SCREW ADVANCED INTO THE PLATE, SPIRALS FROM THE SCREW WERE MADE. THE SPIRALS WERE REMOVED AND IT WAS POSSIBLE TO FULLY ADVANCE THE SCREW WITH NO FURTHER PROBLEMS. THERE WAS NO SURGICAL DELAY. THIS REPORT INVOLVES ONE (1) 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 42MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18029987 ↗
• InjuryMar 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, THE PATIENT UNDERWENT REVISION DUE TO SWELLLING, INFECTION(SEPSIS), PAIN AND IMPLANT FAILURE. XRAY AND ULTRASOUND CONFIRMED THAT THE HARDWARE IN HIS ANKLE HAS FAILED. THE PATIENT IS CURRENTLY TAKING BOTH ORAL AND IV ANTIBIOTICS. ON (B)(6) 2021 THE PATIENT WAS IMPLANTED WITH SYNTHES DEVICES ON LEFT ANKLE AFTER FALLING FROM A TREE. THIS REPORT IS FOR ONE (1) 2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 42. THIS IS REPORT 4 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 16568882 ↗
• MalfunctionFeb 25, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON UNKNOWN DATE, PATIENT UNDERWENT AN UNKNOWN PROCEDURE. INTRA-OPERATIVELY, SOME OF THE LOCKING SCREWS WOULD NOT LOCK INTO THE PLATE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: 2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PL/12 HOLES/RIGHT (PART # 02.118.210, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1)2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 42MM. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11381818 ↗
• InjuryMay 24, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THERE WERE SEVEN (7) PLATES AND TWENTY-SIX (26) SCREWS REMOVED. THIS COMPLAINT INVOLVES THIRTY-THREE (33) DEVICES. THIS IS REPORT 5 OF 10 FOR (B)(4). THIS COMPLAINT HAS BEEN UPDATED WITH THE 5 OF 33 DEVICES. PLEASE SEE THE LINKED COMPLAINTS (B)(4) FOR ADDITIONAL DEVICES.

  Patient problems: Bone Fracture(s); Nonunion/Delayed-union Bone Fracture

  MAUDE report 8640341 ↗