MAUDE Adverse Event Report: SYNTHES BRANDYWINE POLYETHYLENE INLAY W/TANTALUM MARKER/MEDIUM-10MM-STERILE

Catalog Number PDL-M-PT10S

Device Problems Accessory Incompatible (1004); Loose or Intermittent Connection (1371); Difficult To Position (1467); Device Slipped (1584)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/10/2014

Event Type  malfunction  

Event Description

The patient was diagnosed with degenerative disc disease due to lumbar neuritis and underwent a total disc replacement at l5-s1 with prodisc-l on (b)(6) 2014.When the surgeon was inserting the prodisc-l poly insert, it would not fully seat/lock into the inferior end plate when using the applicable inserter and inlay pusher instrument.The surgeon tried several times and described that the pusher seemed to not match up with the poly and would skive off or the pusher would not seat all the way down the inserter.The poly was seventy five percent of the way into the end plate but after several attempts, the surgeon said the poly insert just would not lock in as it should.The surgeon was able to remove the poly, and after inspection determined it should be replaced.Another poly insert was opened, and another attempt to seat this new poly into the end plate was made.However, the same issue occurred and it would not lock properly into the end plate when using the pusher.The surgeon then had to remove the poly, the inferior end plate, and the superior end plate.The surgeon was able to lock the poly insert into the inferior end plate by hand outside the patient.The surgeon then inserted the pdl implant en bloc (inferior end plate, superior end plate, and poly insert) using the inserter into the patient without any problem.X-rays confirmed ideal placement both on the lateral and ap images.Surgeon was satisfied with final placement.The problems with the poly inserts and/or the inserter and/or the pusher delayed the surgery approximately 5 minutes.The surgeon did not feel there was any direct harm to the patient, and was pleased with the final result.Patient is doing fine.This is 1 of 6 reports for complaint (b)(4).

Manufacturer Narrative

(b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history record revealed no complaint related anomalies.Placeholder.

• Brand Name: POLYETHYLENE INLAY W/TANTALUM MARKER/MEDIUM-10MM-STERILE
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: jennifer stout ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 3606658
• MDR Text Key: 4091393
• Report Number: 2530088-2014-00023
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• PMA/PMN Number: P050010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2015
• Device Catalogue Number: PDL-M-PT10S
• Device Lot Number: 6908985
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2012
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 88