NA 03.820.129Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705034731681), received between Feb 11, 2019 and Aug 19, 2019 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 19, 2019Break; Break

  IT WAS REPORTED THAT DURING INSERTION OF A PRODISC-C (PDC) IMPLANT ON 1ST LEVEL (C4-C5) ON (B)(6) 2019, THE TONG THAT CAPTURES THE IMPLANT BROKE OFF. THE IMPLANT WAS AT THE FINAL POSITION. THE SMALL BROKEN PIECE WAS CAPTURED AND REMOVED. PATIENT AND PROCEDURE OUTCOME ARE UNKNOWN. CONCOMITANT DEVICES: PRODISC C IMPLANT (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR AN IMPLANT INSERTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8905660 ↗
• MalfunctionJul 25, 2019Material Twisted/Bent; Mechanical Jam; Material Twisted/Bent; Mechanical Jam

  IT WAS REPORTED ON AN UNKNOWN DATE, TWO PRO DISC CERVICAL IMPLANT INSERTERS WEREN'T WORKING. THE TWO INSERTERS WERE OBSERVED TO HAVE WORN AND GETTING THE INNER-INSERTER SHAFT IN AND OUT WAS VERY DIFFICULT. THE ISSUE WAS DISCOVERED WHEN THE SET WAS CLEANED. THERE WAS NO PATIENT AND SURGICAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) IMPLANT INSERTER. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8826853 ↗
• MalfunctionJul 25, 2019Material Twisted/Bent; Mechanical Jam; Material Twisted/Bent; Mechanical Jam

  IT WAS REPORTED ON AN UNKNOWN DATE, TWO PRODISC CERVICAL IMPLANT INSERTERS WEREN'T WORKING. THE TWO INSERTERS WERE OBSERVED TO HAVE WORN AND GETTING THE INNER-INSERTER SHAFT IN AND OUT WAS VERY DIFFICULT. THE ISSUE WAS DISCOVERED WHEN THE SET WAS CLEANED. THERE WAS NO PATIENT AND SURGICAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) IMPLANT INSERTER. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8826829 ↗
• MalfunctionJul 2, 2019Break; Break

  IT WAS REPORTED ON (B)(6) 2019, DURING THE SURGERY THERE WAS AN UNKNOWN ISSUE OBSERVED WITH THE PRODISC-C (PDC) IMPLANT INSERTER. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. UPON MANUFACTURER RECEIPT AND INVESTIGATION, IT WAS DETERMINED THAT THE DEVICE IS BROKEN. THIS REPORT IS FOR AN IMPLANT INSERTER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8755596 ↗
• MalfunctionJun 5, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNKNOWN PROCEDURE, THE IMPLANT INSERTER SUFFERED A BROKEN TIP. THE TIP WAS RECOVERED FROM THE PATIENT. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8672521 ↗
• MalfunctionMay 16, 2019Break; Break

  IT IS REPORTED THAT ON AN UNKNOWN DATE, ONE (1) PRODISC C IMPLANT INSERTER AND TWO (2) PRODISC L INSERTER-LARGE ARE BROKEN. IT WAS UNKNOWN WHEN THE ISSUE WAS DISCOVERED. IT IS UNKNOWN IF THERE WERE PATIENT AND PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) IMPLANT INSERTER. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8616715 ↗
• MalfunctionApr 18, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, THE IMPLANT INSERTER WAS NOT HOLDING THE PRODISC-C IMPLANT SECURELY. THE DEVICE FAILED TO MAINTAIN A SECURE HOLD OF THE IMPLANT AS THE IMPLANT WAS BEING INSERTED IN PLACE. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PATIENT STATUS AND PROCEDURE OUTCOME ARE UNKNOWN. CONCOMITANT DEVICES: PRODISC-C, IMPLANT (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN). THIS REPORT IS FOR AN IMPLANT INSERTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8527523 ↗
• MalfunctionApr 16, 2019Break; Break

  CONCOMITANT DEVICE REPORTED: PRODISC-C IMPLANT MEDIUM 7MM (PART #: 09.820.027S, LOT #: H495022, QUANTITY: 1) AND UNKNOWN HAMMER (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY 1).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8520323 ↗
• MalfunctionFeb 11, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING THE PREPARATION FOR CLEANING AFTER THE SURGERY AT THE BACK TABLE, THE PRODISC IMPLANT INSERTER BROKE. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8327846 ↗