QUINTEX SC503TRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046963814175), received between Jun 8, 2021 and Jun 9, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Product Quality Problem” (2 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. 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 9, 2021Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT A QUINTEX SEMICONSTRAINED SCREW 4.0X16MM (PART # SC503T) WAS USED DURING AN ANTERIOR CERVICAL FUSION PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, WHILE ATTEMPTING TO SEAT THE 16 MILLIMETER (MM) QUINTEX SCREW, THE INNER SILVER BUSHING KEPT POPPING OUT. THIS OCCURRED ON THREE (3) CONSECUTIVE 16MM SCREWS (REF. ASSOCIATED MDR ID 9610612-2021-00428). THE PHYSICIAN SWITCHED TO THE 14MM SCREWS AND WAS ABLE TO CONTINUE AND SUCCESSFULLY COMPLETE THE PROCEDURE. REPORTEDLY, THE PROBLEM OCCURRED PRIOR TO THE SCREW BEING FULLY SEATED INTO THE PLATE AND WHILE THE SCREWDRIVER WAS STILL ENGAGED IN THE SCREW. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THERE WAS NO SURGICAL DELAY. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE MALFUNCTION IS FILED UNDER (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00428 ((B)(4) + SC503T)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11971029 ↗
• MalfunctionJun 8, 2021Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH SC503T - QUINTEX SEMICONSTRAINED SCREW 4.0X16MM. ACCORDING TO THE COMPLAINT DESCRIPTION, THE 16MM QUINTEX SCREW X3 UPON SEATING THE SCREW, THE INNER SILVER BUSHING KEPT POPPING OUT. THIS HAPPENED ON 3 CONSECUTIVE 16MM SCREWS. WE SWITCHED TO 14MM SCREWS AND THEY WORKED JUST FINE. THIS WAS PRIOR TO THE SCREW BEING FULLY SEATED INTO THE PLATE AND WHILE THE SCREWDRIVER WAS STILL ENGAGED IN THE SCREW. THERE WAS NO SURGERY DELAY, THE ONLY INTERVENTION WAS SWITCHING THE SCREWS AND THE PATIENT OUTCOME WAS GOOD. THERE WAS NO DESCRIBED PATIENT HARM. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE / WAS NOT AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00453 (400515657 + SC503T).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11960488 ↗