USS VAS 499.375Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034793887), received between Apr 13, 2018 and Apr 13, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2018Break; Break

  IT WAS REPORTED DURING A REVISION SURGERY THAT THE REMOVAL OF S1 SCREWS THAT TWO IMPLANT HOLDERS BROKE. ADDITIONALLY, WHILE REPLACING THE RIGHT S1 SCREW, TWO UNIVERSAL SPINE SYSTEM-VARIABLE ANGLE SCREWS (USS-VAS) BROKE - (THE LOCKING RING ON THE SCREW BECAME DISLODGED AND WOULD NOT WORK). A THIRD IMPLANT HOLDER BROKE DURING FINAL TIGHTENING, AND A TIP OF THE HOLDER BROKE OFF INTO THE LEFT S1 SCREW AND WAS NOT RETRIEVABLE. IT REMAINED IN THE PATIENT. WHILE INSPECTING THE USS-VAS SCREWDRIVERS, IT WAS DISCOVERED THAT THE TIPS OF THE DRIVERS WERE TWISTED. REPLACEMENTS WERE REQUESTED. THE REVISION SURGERY WAS CAPTURED AS A POSTOPERATIVE EVENT ON A RELATED PRODUCT COMPLAINT (B)(4). CONCOMITANT DEVICES REPORTED: UNKNOWN USS SCREWS (PART UNKNOWN, LOT UNKNOWN, QUANTITY 3). THIS IS REPORT 5 OF 7 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7429763 ↗
• MalfunctionApr 13, 2018Break; Break

  IT WAS REPORTED DURING A REVISION SURGERY THAT THE REMOVAL OF S1 SCREWS THAT TWO IMPLANT HOLDERS BROKE. ADDITIONALLY, WHILE REPLACING THE RIGHT S1 SCREW, TWO UNIVERSAL SPINE SYSTEM-VARIABLE ANGLE SCREWS (USS-VAS) BROKE - (THE LOCKING RING ON THE SCREW BECAME DISLODGED AND WOULD NOT WORK). A THIRD IMPLANT HOLDER BROKE DURING FINAL TIGHTENING, AND A TIP OF THE HOLDER BROKE OFF INTO THE LEFT S1 SCREW AND WAS NOT RETRIEVABLE. IT REMAINED IN THE PATIENT. WHILE INSPECTING THE USS-VAS SCREWDRIVERS, IT WAS DISCOVERED THAT THE TIPS OF THE DRIVERS WERE TWISTED. REPLACEMENTS WERE REQUESTED. THE REVISION SURGERY WAS CAPTURED AS A POSTOPERATIVE EVENT ON A RELATED PRODUCT COMPLAINT (B)(4). CONCOMITANT DEVICES REPORTED: UNKNOWN USS SCREWS (PART UNKNOWN, LOT UNKNOWN, QUANTITY 3). THIS IS REPORT 4 OF 7 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7429731 ↗