MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SUPERIOR END PLATE LARGE 11°-STERILE; PROSTHESIS INTERVERTEBRAL DISC

Model Number	PDL-L-SP11S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was 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.
Event or Problem Description
It was reported that on (b)(6) 2019, the surgeon had a 2 level prodisc-l and was having trouble getting the polyethylene inlays to go into the implanted endplates during an unknown procedure.The surgeon thought the angle of the access might be putting pressure on the inserter causing the problems.However, the surgeon tried a couple of different poly inlays and changed out the endplates trying to find a resolution.After several attempts the surgeon put the implants together on the back table and inserted it as one piece.After the case, surgeon played with the inserter and a demo implant and couldn't find anything apparently wrong with the instrumentation.It was unknown if there was surgical delay.Surgical procedure outcome and patient outcome were unknown.Concomitant device reported: unknown inserter (part# unknown, lot# unknown, quantity 1).This report is for one (1) superior end plate large 11°-sterile.This is report 5 of 7 for complaint (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: device history lot part number: pdl-l-sp11s, lot number: h409598, part manufacture date: 03/08/2018, manufacturing location: brandywine, part expiration date: oct 31, 2022.Dhr record review: a review of the device history record of this lot revealed no complaint-related anomalies.The device history record shows that the implant was processed through the normal manufacturing and inspection operations.A nonconformance ((b)(4)) was noted at the final brandywine dhr review operation that is determined as not relevant to the complaint.The documentation nonconformance was for a missing page of the packaging-tray testing inspection form (b)(4) that identifies that no testing was required for the subject lot.Nonconformance (b)(4) is not relevant to the complaint as the documentation defect affecting the packaging inspection form would not contribute to the functional basis of this complaint.The lot met all dimensional, visual and packaging criteria.Additional data device was 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: SUPERIOR END PLATE LARGE 11°-STERILE
• Common Device Name: PROSTHESIS INTERVERTEBRAL DISC
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8739949
• Report Number: 2939274-2019-58886
• Device Sequence Number: 2473608
• Product Code: MJO
• UDI-Device Identifier: 10705034700090
• UDI-Public: (01)10705034700090
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P050010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: PDL-L-SP11S
• Device Catalogue Number: PDL-L-SP11S
• Device Lot Number: H409598
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/03/2019
• Supplement Date Received by Manufacturer: 07/24/2019
• Initial Report FDA Received Date: 06/27/2019
• Supplement Report FDA Received Date: 07/25/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - INSERTION INSTRUMENTS; UNK - INSERTION INSTRUMENTS