OPTILINK 42.231.270Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982259516), received between Apr 11, 2023 and Apr 4, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Break” (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 18, 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.

• InjuryApr 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVISION SURGERY OCCURRED (B)(6) 2024 DUE TO A MALUNION/NONUNION. SURGEON REMOVED ALL IMPLANTS THAT WERE CURRENTLY IN PATIENT. RIA WAS USED TO COLLECT BONE GRAFT AND CLEAN OUT THE SURGICAL SITE. SURGEON INSERTED NEW IMPLANTS AFTER RESTORING ALIGNMENT AND LENGTH. ORIGINAL IMPLANT DATE UNKNOWN. IT IS NOT KNOWN HOW LONG THE DEVICES HAVE BEEN IMPLANTED FOR. THIS REPORT IS FOR ONE 5.0MM VAL SCREW/OPTILINK(TM) SLF-TPNG/STRDRV/70MM FOR (B)(4).

  Patient problems: Malunion of Bone; Nonunion/Delayed-union Bone Fracture

  MAUDE report 19044471 ↗
• InjuryApr 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVISION SURGERY OCCURRED (B)(6), 2024 DUE TO A MALUNION/NONUNION. SURGEON REMOVED ALL IMPLANTS THAT WERE CURRENTLY IN PATIENT. RIA WAS USED TO COLLECT BONE GRAFT AND CLEAN OUT THE SURGICAL SITE. SURGEON INSERTED NEW IMPLANTS AFTER RESTORING ALIGNMENT AND LENGTH. ORIGINAL IMPLANT DATE UNKNOWN. IT IS NOT KNOWN HOW LONG THE DEVICES HAVE BEEN IMPLANTED FOR. THIS REPORT IS FOR ONE 5.0MM VAL SCREW/OPTILINK(TM) SLF-TPNG/STRDRV/70MM FOR (B)(4).

  Patient problems: Malunion of Bone; Nonunion/Delayed-union Bone Fracture

  MAUDE report 19044073 ↗
• InjuryDec 12, 2023Migration; Migration

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023, THERE WAS A BACKOUT OF THE OPTILINK SCREW THROUGH AN LAW PLATE AND OVER ADVANCEMENT OF THE INTERLOCK IN AN RFNA STANDARD BEND NAIL. THE PATIENT HAD ADDITIONAL SURGERY ON (B)(6) 2023 TO REMOVE THE SCREW. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 5.0MM VAL SCREW/OPTILINK(TM) SLF-TPNG/STRDRV/70MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18311163 ↗
• 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/STRIDER/70MM. THIS IS REPORT 4 OF 10 FOR (B)(4).

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

  MAUDE report 16712915 ↗