USS 498.813Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034791753), received between Oct 15, 2019 and Oct 15, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionOct 15, 2019Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING A LUMBAR ARTHRODESIS PROCEDURE THE SURGEON WAS UNABLE TO ADJUST THE TWO (2) LOCKING CAPS AND COULD NOT INSERT THE TWO (2) CROSS-LINK CLAMPS. THE PATIENT STATUS IS STABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), SCREWDRIVER SHAFT 3.5 WITH HEXAGONAL QUICK COUPLING 6.0MM FOR CLICK X (PART # 388.079, LOT # UNKNOWN, QUANTITY 1), SCREWDRIVER SHAFT 3.5 MM LONG WITH HEXAGONAL QUICK COUPLING 6.0 M, FOR CLICK X (PART # 388.329, LOT # UNKNOWN, QUANTITY 1), CLICKX LOCK CAP (PART # 498.570, LOT # UNKNOWN, QUANTITY 1), CLICKX LOCK CAP (PART # 04.606.000, LOT # UNKNOWN, QUANTITY 5). THIS REPORT IS FOR ONE (1) CROSS-LINK-CLAMP F/R Ø6 PREASSEMBLE TAN DB. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9192811 ↗