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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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 1 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

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 ↗

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Sources and updates

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