OPTILINK 42.231.280Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982259530), received between Jul 13, 2022 and Apr 11, 2023 — classified as 5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 11, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A FEMALE PATIENT UNFORTUNATELY FELL INJURING HER RIGHT FEMUR. ON (B)(6) 2021 THE PATIENT UNDERWENT OPEN REDUCTION AND INTERNAL FIXATION, RIGHT SUPRACONDYLAR PERIPROSTHETIC FEMUR FRACTURE AND IMPLANTABLE BONE STIMULATOR PLACEMENT. ON (B)(6) 2021, THE PATIENT UNDERWENT REVISION OPEN REDUCTION INTERNAL FIXATION RIGHT SUPRACONDYLAR PERIPROSTHETIC FEMUR FRACTURE, PLACEMENT OF IMPLANTABLE BONE STIMULATOR, PLACEMENT OF ALLOGRAFT BONE DUE TO REFRACTURE OF RIGHT FEMUR AND INTERNAL HARDWARE FRACTURE. SHE HAS A DELAYED UNION AND FELT SIGNIFICANT PAIN IN HER LEFT THIGH. THIS REPORT IS FOR A 5.0MM VAL SCREW/OPTILINK(TM) SLF-TPNG/STRDRV/80MM. THIS IS REPORT 8 OF 10 FOR (B)(4).

  Patient problems: Fall; Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 16712928 ↗
• InjuryApr 11, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A FEMALE PATIENT UNFORTUNATELY FELL INJURING HER RIGHT FEMUR. ON (B)(6) 2021 THE PATIENT UNDERWENT OPEN REDUCTION AND INTERNAL FIXATION, RIGHT SUPRACONDYLAR PERIPROSTHETIC FEMUR FRACTURE AND IMPLANTABLE BONE STIMULATOR PLACEMENT. ON (B)(6) 2021, THE PATIENT UNDERWENT REVISION OPEN REDUCTION INTERNAL FIXATION RIGHT SUPRACONDYLAR PERIPROSTHETIC FEMUR FRACTURE, PLACEMENT OF IMPLANTABLE BONE STIMULATOR, PLACEMENT OF ALLOGRAFT BONE DUE TO REFRACTURE OF RIGHT FEMUR AND INTERNAL HARDWARE FRACTURE. SHE HAS A DELAYED UNION AND FELT SIGNIFICANT PAIN IN HER LEFT THIGH. THIS REPORT IS FOR A 5.0MM VAL SCREW/OPTILINK(TM) SELF-TYPING/STRDRV/80MM. THIS IS REPORT 2 OF 10 FOR (B)(4).

  Patient problems: Fall; Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 16712902 ↗
• 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/80. THIS IS REPORT 5 OF 12 FOR COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 16709633 ↗
• InjuryDec 14, 2022Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2022, THERE WAS SCREW BACKOUT FOUND ON A RFNA NAIL CASE ORIGINALLY IMPLANTED ON (B)(6) 2022. THE SURGEON PERFORMED A REVISION, REMOVING ONE OBLIQUE SCREW WITHOUT REPLACEMENT, AND REPLACING TWO LOCKING SCREWS INTO THE LAW PLATE. PATIENT IMPACT IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 5.0MM VAL SCREW/OPTILINK(TM) SLF-TPNG/STRDRV/80MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15982296 ↗
• InjuryJul 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2022, THAT THERE WAS REMOVAL OF HARDWARE AND REVISION. NON UNION RIGHT FEMUR. ALL HARDWARE WAS REMOVED WITHOUT COMPLICATION. THERE WERE NO BROKEN IMPLANTS. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT WAS DOING WELL AFTER POST OP. THIS REPORT IS FOR ONE (1) 5.0 VAL SCREOPTILINK(TM) SLF-TPNG/SD/80. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 14998934 ↗