OsteoMed 400-3701-SPRecalls & reported problems
Osteomed LLC · InstaFix Implant Kit, 8x8mm · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00842528104170), received between Oct 2, 2022 and Oct 2, 2022 — classified as 2 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
Device problems
- Break2
Patient problems
- Nonunion/Delayed-union Bone Fracture2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 2, 2022Break; Break
IT WAS REPORTED THE PATIENT UNDERWENT THE INITIAL IMPLANT PROCEDURE FOR HALLUX INTERPHALANGEAL JOINT FUSION ON (B)(6) 2022. THE SURGEON REPORTED THE PATIENT HAD A NON-UNION AND ONE (1) OF THE TWO (2) 10 X 10 INSTAFIX STAPLES HAD BROKEN AT THE CORNER (EVENT DATE UNKNOWN). ON (B)(6) 2022, THE SURGEON EXPLANTED BOTH INSTAFIX STAPLES, DEBRIDED, FENESTRATED, ADDED DBM PUTTY, AND PLACED TWO (2) 15 X 10MM INSTAFIX STAPLES. IT WAS INDICATED THE EXPLANTED INSTAFIX STAPLES WERE NOT AVAILABLE TO BE RETURNED FOR EVALUATION. THIS REPORT IS RELATED TO REPORT NUMBER 2027754-2022-00049 FOR THE OTHER EXPLANTED INSTAFIX STAPLE.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 15526251 ↗InjuryOct 2, 2022Break; Break
IT WAS REPORTED THE PATIENT UNDERWENT THE INITIAL IMPLANT PROCEDURE FOR HALLUX INTERPHALANGEAL JOINT FUSION ON (B)(6) 2022. THE SURGEON REPORTED THE PATIENT HAD A NON-UNION AND ONE OF THE TWO 10 X 10 INSTAFIX STAPLES HAD BROKEN AT THE CORNER (EVENT DATE UNKNOWN). ON (B)(6) 2022, THE SURGEON EXPLANTED BOTH INSTAFIX STAPLES, DEBRIDED, FENESTRATED, ADDED DBM PUTTY, AND PLACED TWO 15 X 10MM INSTAFIX STAPLES. IT WAS INDICATED THE EXPLANTED INSTAFIX STAPLES WERE NOT AVAILABLE TO BE RETURNED FOR EVALUATION. THIS REPORT IS RELATED TO REPORT NUMBER 2027754-2022-00050 FOR THE OTHER EXPLANTED INSTAFIX STAPLE.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 15526250 ↗
Other Staple, fixation, bone devices
- N/A StandardSynthes GmbH · Staple, Fixation, Bone2 recalls16 reports
- GII QUICKANCHOR ETHIBOND 212034Medos International Sàrl · STAPLE, FIXATION, BONE98 reports
- GII QUICKANCHOR ORTHOCORD 222983Medos International Sàrl · STAPLE, FIXATION, BONE94 reports
- Speed SE-0910Synthes GmbH · Staple, Fixation, Bone1 recall24 reports
- Speed Shift SE-2020-10Synthes GmbH · Staple, Fixation, Bone1 recall10 reports
- Lapiplasty SpeedPlate SK50Treace Medical Concepts, Inc. · Staple, Fixation, Bone59 reports
- Speed SE-1512Synthes GmbH · Staple, Fixation, Bone1 recall6 reports
- LUPINE ORTHOCORD 210709Depuy Mitek, LLC · STAPLE, FIXATION, BONE56 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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