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OsteoMed 355-0101Recalls & reported problems

Osteomed LLC · 4 Hole VDR Narrow Plate, Left · Class 2

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 00845694091824), received between Sep 6, 2018 and Sep 6, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Device Dislodged or Dislocated1

Patient problems

  • No Information1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 6, 2018Device Dislodged or Dislocated

    ON 08/10/2018, OSTEOMED WAS NOTIFIED OF AN INCIDENT CONCERNING OUR IMPLANTS. PER THE INFORMATION RECEIVED FROM THE DISTRIBUTOR, THIS WAS THE SECOND OPERATION OF A OSTEOTOMY DISTAL RADIUS. THE ORIF USING VOLAR DISTAL RADIUS PLATING (OTHER BRAND) WAS FAILED. THEN TWO (2) MONTHS AFTER SURGERY ((B)(6) 2018), THE IMPLANT DISPLACED FROM THE BONE AND THE LOCKING MOTION FAILED. FOUR (4) SCREWS WERE USED WITH THE PLATE. HOWEVER, WE HAVE NOT RECEIVED CONFIRMATION OF THE SCREW(S) THAT FAILED (P/NS 359-2412, 359-2420, 359-2712, AND 359-2716). POST OP INSTRUCTIONS GIVEN TO PATIENT: WRIST SPLINT FROM POST OP UNTIL NOW, LIMITED USE OF HAND.

    Patient problems: No Information

    MAUDE report 7853456 ↗

Other Plate, fixation, bone devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.