NA 03.306.001Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982077684), received between Apr 21, 2023 and May 8, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM FRANCE REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT OVER THE COURSE OF MULTIPLE PROCEDURES, THE SYSTEM DID NOT SLIDE AS USUAL. PROGRESSIVELY WITH USE, A PART OF THE SYSTEM GOT JAMMED. SO THERE WAS A FORCED USE ON ONE SIDE. DURING ONE EVENT, AT THE REMOVAL OF THE SYSTEM, THE SIDE THAT USED TO SLIDE NO LONGER SLIDES. THE CONNECTION BETWEEN THE INTERIOR AND EXTERIOR RAILS HAS BEEN DIFFICULT. THE THREADED SLEEVE GOT STUCK IN THE LOWER ARM. THE METAL INSERT SEPARATED FROM THE LOWER ARM. THE SECOND THREADED SLEEVE ALSO SEIZED UP. TO DATE, THE EQUIPMENT IS UNUSABLE. THE SURGEONS HAD TO FORCE TO RELEASE ALL THE PARTS THAT WERE BLOCKED. A SOLUTION HAD TO BE FOUND TO REMOVE THE MATERIAL BLOCKED IN THE PATIENT'S PELVIS. THE SURGEONS HAVE ADOPTED STRATEGIES ALLOWING THE PERFORMANCE OF THE INTERVENTION WITH NO PATIENT CONSEQUENCE. THIS REPORT IS FOR AN OUTER RAIL FOR PELVIC C-CLAMP II. THIS IS REPORT 10 OF 11 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16889414 ↗
• MalfunctionMay 8, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM FRANCE REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT OVER THE COURSE OF MULTIPLE PROCEDURES, THE SYSTEM DID NOT SLIDE AS USUAL. PROGRESSIVELY WITH USE, A PART OF THE SYSTEM GOT JAMMED. SO THERE WAS A FORCED USE ON ONE SIDE. DURING ONE EVENT, AT THE REMOVAL OF THE SYSTEM, THE SIDE THAT USED TO SLIDE NO LONGER SLIDES. THE CONNECTION BETWEEN THE INTERIOR AND EXTERIOR RAILS HAS BEEN DIFFICULT. THE THREADED SLEEVE GOT STUCK IN THE LOWER ARM. THE METAL INSERT SEPARATED FROM THE LOWER ARM. THE SECOND THREADED SLEEVE ALSO SEIZED UP. TO DATE, THE EQUIPMENT IS UNUSABLE. THE SURGEONS HAD TO FORCE TO RELEASE ALL THE PARTS THAT WERE BLOCKED. A SOLUTION HAD TO BE FOUND TO REMOVE THE MATERIAL BLOCKED IN THE PATIENT'S PELVIS. THE SURGEONS HAVE ADOPTED STRATEGIES ALLOWING THE PERFORMANCE OF THE INTERVENTION WITH NO PATIENT CONSEQUENCE. THIS REPORT IS FOR AN OUTER RAIL FOR PELVIC C-CLAMP II. THIS IS REPORT 2 OF 11 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16887840 ↗
• MalfunctionApr 21, 2023Device-Device Incompatibility; Device-Device Incompatibility

  THERE WAS NO CHANGE OF SURGICAL TECHNIQUE. THE SYSTEM WAS USED FOR RETAINING BONES DURING PELVIS SURGERIES. AFTER SOME USES, THE SYSTEM DID NOT USUALLY SLIDE AS USUAL. PROGRESSIVELY WITH USES, A PART OF THE SYSTEM WAS JAMMED. SO THERE WAS A FORCED USE ON ONE SIDE. DURING THIS EVENT, AT THE REMOVAL OF THE SYSTEM, THE SIDE THAT USED TO SLIDE NO LONGER. THE SURGEONS HAD ADOPTED STRATEGIES ALLOWING THE PERFORMANCE OF THE INTERVENTION WITH NO PATIENT CONSEQUENCE. THIS IS REPORT 12 OF 13 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16791933 ↗
• MalfunctionApr 21, 2023Device-Device Incompatibility; Device-Device Incompatibility

  THERE WAS NO CHANGE OF SURGICAL TECHNIQUE. THE SYSTEM WAS USED FOR RETAINING BONES DURING PELVIS SURGERIES. AFTER SOME USES, THE SYSTEM DID NOT USUALLY SLIDE AS USUAL. PROGRESSIVELY WITH USES, A PART OF THE SYSTEM WAS JAMMED. SO THERE WAS A FORCED USE ON ONE SIDE. DURING THIS EVENT, AT THE REMOVAL OF THE SYSTEM, THE SIDE THAT USED TO SLIDE NO LONGER. THE SURGEONS HAD ADOPTED STRATEGIES ALLOWING THE PERFORMANCE OF THE INTERVENTION WITH NO PATIENT CONSEQUENCE. THIS IS REPORT 6 OF 13 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16791494 ↗