OsteoMed 359-2712Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00845694093323), received between Sep 7, 2018 and Jun 25, 2020 — classified as 2 malfunctions.

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  ON MAY 28, 2020, OSTEOMED WAS NOTIFIED THAT AN IMPLANTED 2.7MM X 12MM VARIABLE ANGLE LOCKING SCREW (P/N 359-2712) AND ASSOCIATED SCREWS AND PLATES WERE FOUND TO HAVE MIGRATED FROM THE IMPLANTED LOCATION. THE INITIAL IMPLANT WAS PERFORMED ON (B)(6) 2020 AND THE PRODUCTS WERE EXPLANTED ON (B)(6) 2020. AS PER SURGEON REPORT "I SAW THE PATIENT AFTER 2 WEEKS AND NO COMPLICATIONS WERE SPOTTED. DUE TO THE SITUATION I SUGGESTED NOT TO START THE REHABILITATION UNTIL THE 4TH POST-OPERATIVE WEEK. AFTER 4 WEEKS SHE CAME TO MY ATTENTION WITH PAIN AND A SEVERE ALTERATION OF THE NORMAL WRIST ANATOMY. NO TRAUMA WAS REPORTED BY THE PATIENT AND HER FAMILY MEMBERS. THE X-RAY SHOWED EARLY FAILURE OF THE IMPLANT, DISPLACEMENT OF THE FRACTURE AND MIGRATION OF TWO SCREWS. DURING THE PROCEDURE I'VE FOUND COMPLETE LOOSENING OF ALL THE SCREWS WITH THE ONLY EXCEPTION OF THE MOST PROXIMAL ONE, INCLUDING ALL THE LOCKING SCREWS. ONE SCREWS WAS FOUND 1.5 CM OUTSIDE OF THE PLATE AND STILL INSERTED ON THE PLATE HOLE, ONE WAS COMPLETELY EXPELLED (LOCKING SCREW AS WELL) AND WAS FOUND WITHIN THE FLEXOR TENDONS LYING CLOSE TO THE MEDIAN NERVE." THE FOLLOWING IMPLANTS (PLATE AND SCREWS) WERE INVOLVED WITH THIS INCIDENT

  Patient problems: Bone Fracture(s)

  MAUDE report 10197855 ↗
• MalfunctionSep 7, 2018Device Dislodged or Dislocated

  ON (B)(6) 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 SCEW(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 7856922 ↗