NA 04.633.404Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034746784), received between Oct 6, 2017 and Oct 6, 2017 — classified as 1 injury.

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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 6, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT REVISION SURGERY WAS COMPLETED ON (B)(6) 2017. THE PATIENT WAS IMPLANTED WITH SYNTHES CLICK X AND PANGEA SCREWS AS WELL AS DEPUY SCREWS MORE THAN 5 YEARS AGO. THE ENTIRE CONSTRUCT IS FROM T-11 TO L-5. THE PATIENT WAS THEN IMPLANTED WITH MATRIX CONNECTORS AND RODS TO JOIN TOGETHER THE SYNTHES AND DEPUY SCREWS ON (B)(6) 2017. THE PATIENT WAS INVOLVED IN A CAR ACCIDENT ON AN UNKNOWN DATE AND PRESENTED WITH PAIN. HE FOLLOWED UP WITH THE SURGEON IN THE BEGINNING OF SEPTEMBER AND IT WAS DISCOVERED THAT THE CONNECTORS DISCONNECTED FROM THE RODS ON THE L-2 TO L-3. THE PATIENT WAS REVISED WITH A SYNTHES TRANSITIONAL ROD AND THE LOCKING CAPS WERE REPLACED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO REPORT OF PATIENT HARM. THERE ARE 2 DEVICES IN THIS COMPLAINT CONCOMITANT DEVICES REPORTED: RODS (PART# 04.620.160, LOT# 1526511, QUANTITY 2) DEPUY SPINE SCREWS (PART # 1791-71-085, LOT# BDHT1SY, QUANTITY 1). THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 6924068 ↗