NA PDL404Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705034700564), received between Dec 29, 2016 and Jun 27, 2019 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 27, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE LARGE INSERTER WAS DISCOVERED BROKEN AND DAMAGED IN THE STERILE TRAY PRIOR TO BRINGING THE PATIENT INTO THE OPERATING ROOM (OR). THE SURGICAL TECHNOLOGIST FOUND THE INSTRUMENT AND THE INSTRUMENT COULD NOT BE USED IN THE CASE. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM INCURRED. THIS REPORT IS FOR ONE (1) INSERTER-LARGE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8741153 ↗
• 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) INSERTER-LARGE. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8616787 ↗
• 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) INSERTER-LARGE. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8616775 ↗
• MalfunctionMar 2, 2017Break; Break

  IT WAS REPORTED THAT THE SERVICE AND REPAIR DEPARTMENT DOCUMENTED THAT SYNTHES EVALUATION EQUIPMENT-BROKEN SHAFT. SHAFT IS NOT CONNECTED TO THE PART. THE ISSUE WAS IDENTIFIED DURING INSPECTION ACTIVITIES OF THE EVALUATION SET. THERE WERE NO ISSUES REPORTED BY THE CUSTOMER. SALES CONSULTANT CONFIRMED THAT THERE WAS NO ISSUE WITH THE DEVICE WHEN IT WAS USED. THE SALES CONSULTANT DID NOT FILE A COMPLAINT AGAINST THE DEVICE. AS STATED BY SERVICE AND REPAIR, THE ISSUE WAS IDENTIFIED DURING INSPECTION. THIS IS REPORT 1 OF 1 FOR COM-(B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6374597 ↗
• InjuryDec 29, 2016Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE TO IMPLANT A SYNTHES PRODISC LUMBAR (PDL) IMPLANT AT AN UNKNOWN LEVEL ON (B)(6) 2016. DURING THE PROCEDURE, WHILE INSERTING THE IMPLANT INTO THE DISC SPACE, THE SURGEON NOTED THE IMPLANT APPEARED TO BE MALPOSITIONED. WHEN THE SURGEON ATTEMPTED TO REPOSITION THE IMPLANT AND CENTER THE DEVICE, THE PINS ON THE END OF THE INSERTER BROKE OFF INSIDE OF THE IMPLANT. THE REPORTED MALFUNCTION REQUIRED THAT THE SURGEON EXPLANT THE DEVICE AND RE-IMPLANT WITH A NEW PDL IMPLANT. A SURGICAL DELAY OF APPROXIMATELY 30 MINUTES WAS REPORTED WHILE THE SURGEON RETRIEVED AN ALTERNATE IMPLANT AND COMPLETED THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS REPORTED AS STABLE. CONCOMITANT DEVICES REPORTED: SUPERIOR ENDPLATE (PART #: PDL-L-SP11S, LOT #: 9941519, QTY. 1), POLYETHYLENE INLAY (PART #: PDL-L-PT10S, LOT #: 9934735, QTY. 1), INFERIOR ENDPLATE (PART #: PDL-L-IP00S, LOT #: 7791561, QTY. 1). THIS REPORT IS FOR ONE (1) INSERTER - LARGE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Sedation

  MAUDE report 6214360 ↗