OPTILINKRecalls & reported problems across all models
Synthes GmbH · 11 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 25
- Deaths reported
- 0
- Injuries reported
- 24
- Recalls
- 0
We found 11 models of OPTILINK by Synthes GmbH in the FDA's device registry (GUDID). Together they are named in 25 adverse event reports in the FDA's MAUDE database, received between Jun 17, 2021 and Apr 4, 2024 — classified as 24 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (11 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported OPTILINK problems
Device problems
- Break11
- Adverse Event Without Identified Device or Use Problem10
- Migration3
- Manufacturing, Packaging or Shipping Problem1
Patient problems
- Pain14
- Nonunion/Delayed-union Bone Fracture12
- Fall9
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
- Failure of Implant2
- Malunion of Bone2
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
OPTILINK models
11 models, most reported first. Each model has its own page with its reports, recalls and device details.
- OPTILINK 42.231.280Cerclage, fixation5 reports
- OPTILINK 42.231.270Cerclage, fixation4 reports
- OPTILINK 42.231.220Cerclage, fixation3 reports
- OPTILINK 42.231.234Cerclage, fixation3 reports
- OPTILINK 42.231.260Cerclage, fixation2 reports
- OPTILINK 42.231.275Cerclage, fixation2 reports
- OPTILINK 42.231.295SCerclage, fixation2 reports
- OPTILINK 42.231.655Cerclage, fixation1 report
- OPTILINK 42.231.222Cerclage, fixation1 report
- OPTILINK 42.231.255Cerclage, fixation1 report
- OPTILINK 42.231.018Cerclage, fixation1 report
Recent OPTILINK adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionMar 19, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE VA CANN-LOCK-SCRØ5.0 OPTILINK TECHN L65 ARRIVED IN THE CORRECT PACKAGING, BUT INSIDE WAS AN INCORRECT SCREW SIZE. DUE TO THE PACKAGING BEING CORRECT, IT WAS OPENED AND THEN DISCOVERED TO BE THE WRONG SIZE SCREW INSIDE. IT IS UNKNOWN IF THERE WERE PATIENT AND PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) 5.0MM CANN VAL SCREW OPTILINK(TM)/55MM THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18928617 ↗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) 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) SLF-TPNG/STRDRV/34MM. THIS IS REPORT 9 OF 10 FOR (B)(4).
Patient problems: Fall; Nonunion/Delayed-union Bone Fracture; Pain
MAUDE report 16712927 ↗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/34MM. THIS IS REPORT 10 OF 10 FOR (B)(4).
Patient problems: Fall; Nonunion/Delayed-union Bone Fracture; Pain
MAUDE report 16712924 ↗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/34MM. THIS IS REPORT 7 OF 10 FOR (B)(4).
Patient problems: Fall; Nonunion/Delayed-union Bone Fracture; Pain
MAUDE report 16712920 ↗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/55MM. THIS IS REPORT 5 OF 10 FOR (B)(4).
Patient problems: Fall; Nonunion/Delayed-union Bone Fracture; Pain
MAUDE report 16712916 ↗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 ↗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/60MM. THIS IS REPORT 6 OF 10 FOR (B)(4).
Patient problems: Fall; Nonunion/Delayed-union Bone Fracture; Pain
MAUDE report 16712913 ↗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/75MM. THIS IS REPORT 3 OF 10 FOR (B)(4).
Patient problems: Fall; Nonunion/Delayed-union Bone Fracture; Pain
MAUDE report 16712904 ↗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 PERIPR VAL SCR/18 OPTILINK/SF-TPG/SD THIS IS REPORT 11 OF 12 FOR COMPLAINT (B)(4).
Patient problems: Pain
MAUDE report 16709679 ↗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 ↗
Other Synthes GmbH products
All Synthes GmbH devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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