NA 03.118.008Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982073372), received between Sep 6, 2022 and Aug 8, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (8 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

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 8, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE COMPRESSION DISTRACTION POST FOR VA LOCKING SCREW HAS THREADS STRIPPED. THE ISSUE IDENTIFIED DURING INSPECTION. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22751611 ↗
• MalfunctionAug 8, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE COMPRESSION DISTRACTION POST FOR VA LOCKING SCREW HAS THREADS STRIPPED. THE ISSUE IDENTIFIED DURING INSPECTION. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22751610 ↗
• MalfunctionAug 8, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE COMPRESSION DISTRACTION POST FOR VA LOCKING SCREW HAS THREADS STRIPPED. THE ISSUE IDENTIFIED DURING INSPECTION. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22751608 ↗
• MalfunctionAug 8, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE COMPRESSION DISTRACTION POST FOR VA LOCKING SCREW HAS THREADS STRIPPED. THE ISSUE IDENTIFIED DURING INSPECTION. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22751605 ↗
• MalfunctionAug 8, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE COMPRESSION DISTRACTION POST FOR VA LOCKING SCREW HAS THREADS STRIPPED. THE ISSUE IDENTIFIED DURING INSPECTION. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22751603 ↗
• MalfunctionAug 8, 2025Material Twisted/Bent; Material Twisted/Bent

  THE FOLLOWING PRODUCT ISSUES WERE REPORTED TO HAVE OCCURRED ON AN UNKNOWN DATE: DEPTH GAUGE FOR 3.5MM CORTEX SCREWS (X 3) - HOOK IS BROKEN FROM USAGE IN PELVIS. RATCHET WRENCH-11MM WIDTH ACROSS FLATS (X 3) - RATCHET DOESN¿T WORK. 2.4/2.7 VOLT(TM) SCR RACK 6-90 2 HIGH 1/3 WIDTH ALUM FRAME (X 2) - RACKS ARE FADED FROM WASH AND SOAP. 1.6MM/0.8MM DOUBLE DRILL GUIDE (X 2) - GUIDE IS BENT. 2.0MM/1.1MM DOUBLE DRILL GUIDE (X 2) - GUIDE IS BENT. 2.7MM COMPRESSION/DISTRACTION POST/FOR VA-LOCKING HOLE X 6- THREADS ARE STRIPPED. 2.8MM GUIDE WIRE/ 300MM LENGTH FLUTED TIP (X 6) - THREADS STRIPPED. 2.7MM VOLT(TM) CONDYLAR PLATE 6H/58MM (X 1) - PLATE DID NOT LOCK WITH LOCKING SCREW. 2.7MM VOLT(TM) CONDYLAR PLATE 10H/95MM (X 1) PLATE DID NOT LOCK WITH LOCKING SCREW. 15.5MM MONOBLOC FLEXIBLE REAMER - LONG (X 2) - REAMERS ARE DULL. PERIOSTEAL ELEVATOR 14MM STRAIGHT BLADE-ROUND EDGE (X 3) - RUST ON ELEVATOR. THERE WAS NO PATIENT INVOLVEMENT; ISSUES WERE NOTED IN STERILE PROCESSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22748424 ↗
• MalfunctionSep 6, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2022 THE THREADED TIP IS DAMAGED AND DENTAL PICK BROKE. NO SURGICAL DELAYED FOR THIS EVENT. NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 2.7 COMP/DISTRACTION POST/FOR VAL HOLE. THIS IS REPORT 2 OF 2 FOR COMPLAINT. (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15366730 ↗
• MalfunctionSep 6, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2022 THE THREADED TIP IS DAMAGED AND DENTAL PICK BROKE. NO SURGICAL DELAYED FOR THIS EVENT. NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 2.7 COMP/DISTRACTION POST/FOR VAL HOLE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15366714 ↗