NA 03.820.000Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034731179), received between Sep 26, 2018 and Sep 26, 2018 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionSep 26, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT, ON AN UNKNOWN DATE, THE HANDLE FOR TRIAL IMPLANTS WAS BINDING AND STICKING PREOPERATIVELY AS THE SURGICAL TECHNICIAN WAS ATTEMPTING TO LOAD A PRODISC C TRIAL ONTO THE T-HANDLE. THE T-HANDLE WAS NOT GRASPING OR HOLDING THE PRODISC C TRIAL PROPERLY. THE T-HANDLE WAS REMOVED FROM THE ROOM PRIOR TO THE INITIATION OF THE CASE. TESTING BY CENTINEL SPINE FOUND THAT VARIOUS PRODISC C TRIALS FIT ONTO THE TRIAL HANDLE WHILE OTHERS THEY TESTED DID NOT. THERE WAS NO APPARENT PATTERN IN PART OR LOT NUMBERS. INSPECTION OF THE 4 MILLIMETER CONNECTION SHOWS A SMALL AREA THAT MAY BE DAMAGED, WHICH DECREASED THE COUNTER BORE IDENTIFICATION (ID). TRIALS WITH THE CONNECTOR ON THE UPPER END OF THE TOLERANCE BAND MAY NOT FIT INTO THIS CONNECTION. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM. CONCOMITANT DEVICES REPORTED: UNKNOWN PRODISC C TRIAL (PART #: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7909821 ↗