OPTILINK 42.231.220Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982259325), received between May 6, 2022 and Apr 10, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (2 reports).

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

• InjuryApr 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, THE PATIENT UNDERWENT HARDWARE REMOVAL DEEP DUE TO RIGHT FEMUR PAINFUL HARDWARE. THE PLATE SCREWS AND STIMULATOR BODIES WERE REMOVED. THE STIMULATOR ELECTRODES WERE ENCASED IN BONE AND WERE NOT EXTRACTED. THIS REPORT IS FOR ONE (1) 5.0 VAL SCREOPTILINK(TM) SLF-TPNG/SD/20. THIS IS REPORT 10 OF 12 FOR COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 16709651 ↗
• InjuryMay 6, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, A PATIENT WITH BOTH LEFT PROSTHETIC DISTAL FEMUR NONUNION WAS TREATED WITH A VA CONDYLAR PLATE. THERE WERE 8 LOCKING SCREWS AND 2 CORTICAL SCREWS, INCLUDING THIS PLATE. THE PLATE WAS REMOVED, SCREWS, TOTAL REMOVED AND BREAKAGE, EVERYTHING WAS REMOVED SUCCESSFULLY. THE PATIENT IS STAYED FOR DISTAL FEMORAL REPLACEMENT WITH THE SURGEON. THERE WAS PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE SCREWS: LOCKING. THIS IS REPORT 2 OF 11 FOR COMPLAINT (B)(4).

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

  MAUDE report 14309377 ↗
• InjuryMay 6, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, A PATIENT WITH BOTH LEFT PROSTHETIC DISTAL FEMUR NONUNION WAS TREATED WITH A VA CONDYLAR PLATE. THERE WERE 8 LOCKING SCREWS AND 2 CORTICAL SCREWS, INCLUDING THIS PLATE. THE PLATE WAS REMOVED, SCREWS, TOTAL REMOVED AND BREAKAGE, EVERYTHING WAS REMOVED SUCCESSFULLY. THE PATIENT IS STAYED FOR DISTAL FEMORAL REPLACEMENT WITH THE SURGEON. THERE WAS PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE SCREWS: LOCKING. THIS IS REPORT 3 OF 11 FOR COMPLAINT (B)(4).

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

  MAUDE report 14309275 ↗