13 X 90mm LAG FASTENER 324-13090Recalls & reported problems
Osteocentric Technologies, Inc. · 13 X 90mm LAG FASTENER · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810189110076), received between Jun 11, 2026 and Jun 11, 2026 — classified as 1 malfunction.
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.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 11, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT FEMORAL NECK FRACTURE REPAIR SURGERY ON (B)(6) 2026. FOLLOW-UP EVALUATION PERFORMED BETWEEN THE INITIAL SURGERY AND (B)(6) 2026 REVEALED THAT THE FRACTURE HAD NOT HEALED. REVISION SURGERY WAS SUBSEQUENTLY PERFORMED ON (B)(6) 2026. DURING THE REVISION PROCEDURE, IT WAS DETERMINED THAT ONE 13 X 90 MM LAG FASTENER (PART 324-13090, LOT HFI042) AND TWO 6.0 X 95 MM BONE SCREW FASTENERS ST (PART 360-1095, LOT HFV009) HAD BROKEN. THE DATE THE DEVICES BROKE IS UNKNOWN. THE 13 X 90 MM LAG FASTENER WAS COMPLETELY REMOVED AND RECOVERED. THE TWO 6.0 X 95 MM BONE SCREW FASTENERS ST WERE PARTIALLY REMOVED, WITH THE DISTAL TIP FRAGMENTS REMAINING IMPLANTED IN THE PATIENT. NO ADDITIONAL ADVERSE PATIENT CONSEQUENCES ASSOCIATED WITH THE REPORTED DEVICE ISSUE WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 25480190 ↗
Other Device, Fixation, Proximal Femoral, Implant devices
- DHS 280.310Synthes GmbH · DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT1 report
- DHS 281.031Synthes GmbH · DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT1 report
- CONQUEST FN 71179203Smith & Nephew, Inc. · DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT1 report
- DHS 281.520SSynthes GmbH · DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT1 report
- CONQUEST FN 75808095Smith & Nephew, Inc. · DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT1 report
- PERCUTANEOUS COMPRESSION PLATE (PC.C.P) 1Orthofix Srl · Device, Fixation, Proximal Femoral, Implant1 report
- DHS 281.021SSynthes GmbH · DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT1 report
- NA 282.238Synthes GmbH · DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT1 report
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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