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

Catalog Number PDL-M-PT10S

Device Problem Fitting Problem (2183)

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

Event Date 07/21/2016

Event Type  malfunction  

Manufacturer Narrative

Device used for treatment, not diagnosis.(b)(6).(b)(4).Not implanted or explanted, device was ex-changed with another inlay.Device is not expected to be returned for manufacturer review/investigation.Device history records review was conducted.The report indicates that the: dhr review for part #pdl-m-pt10s, lot #7803186, release to warehouse date: (b)(6) 2014, expiration date: sep 30, 2017, supplier: (b)(6).No ncrs were generated during production; review of the device history record(s) showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.The investigation could not be completed; no conclusion could be drawn, as no product was received if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that during an initial lumbar disc arthroplasty surgery on the l5, s1, that the superior and interior pro-disc end plates were implanted in the patient with a medium sized pro-disc holder.The surgeon then slide the poly-inlay down the tracks of the holder.The inlay kept popping off the tracks of the holder.The surgeon changed the one poly-inlay with another poly-inlay.The surgeon thought that the defective device was a poly-inlay.The surgeon then switched out the other implant holder, and that did not help.The surgeon kept working to make it function, and the inlay was finally implanted.The surgeon stated that there may be a defect in either the inlay or the two holders.The distance between the tracks may have been either narrower than it should have been, or that the surgeon was not getting the inlay on the track properly.There was about a 20 minute surgical delay.The procedure was completed successfully with no reports of medical intervention.The patient's post-operative status was noted to be stable.This complaint has 4 devices.Concomitant devices reported: part #-pdl-m-sp11s, lot #-7807317, quantity-((b)(4)); pdl-m-it00s, lot #-9911798, quantity-((b)(4)).This report is 1 of 4 for (b)(4).

Manufacturer Narrative

Product investigation was completed: a device history record (dhr) review, visual inspection, partial functional test, and drawing review were performed as part of this investigation.The complaint condition could not be confirmed and no functional or dimensional issues were identified with the returned parts.The returned parts were determined to be suitable for their intended use when employed and maintained as recommended.Thus, as no issues were identified with the returned devices, further investigation is not warranted.The returned medium inserter and medium polyethylene inlay implant are part of the prodisc-l total disc replacement system.The prodisc-l system is ¿intended to replace a diseased and/or degenerated intervertebral disc of the lumbosacral region¿ between l3 and s1.The inserter is used to insert the endplates and then used with the distractor and the inlay pusher to insert the polyethylene inlay.The inserters and implant were received intact with surface wear consistent with use.The measurement across the ledges of the inlay which are the widest portion of the implant and responsible for mating with the inserter were confirmed to be within the specification of 23mm +0/-0.1 at 22.94mm as measured with micrometers om33.The inner edges of the ledges were also confirmed to be within the specification of 21mm +0/-0.1 at 20.93mm as measured with micrometers om33.The slots along the arm component of each inserter were inspected and no damage was observed.The slots properly mated with the returned implant when held in position.However, as the inferior arms of the inserter are designed to rotate and lock into the inferior plate, establishing a fixed distance between the two arms that would allow the polyethylene inlay to slide within the groove, a full functional test could not be performed.Thus, replication of the complaint condition is not applicable as the adjoining implants and instruments were not received.In conclusion, the complaint condition could not be confirmed and no functional or dimensional issues were identified with the returned parts.A review of the current design drawing / manufactured revision for the top level, the inserter arm component with stop, the inserter arm component without stop, the top level and the detailed inlay was performed.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned parts were determined to be suitable for their intended use when employed and maintained as recommended.In conclusion, the complaint condition could not be confirmed and no functional or dimensional issues were identified with the returned parts.Thus, as no issues were identified with the returned devices, further investigation is not warranted.No functional or dimensional issues were identified with the returned parts.Thus, given the unconfirmed condition and the unknown circumstances at the time of the issue a root cause could not be definitively determined.Device used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: POLYETHYLENE INLAY W/TANTALUM MARKER/MEDIUM-10MM-STERILE
• Type of Device: PROSTHESIS INTERVERTEBRAL DISC
• 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: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5860164
• MDR Text Key: 51861448
• Report Number: 2530088-2016-10215
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: PDL-M-PT10S
• Device Lot Number: 7803186
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 95