MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PRODISC-C IMPLANT MEDIUM 6MM-STERILE; PROSTHESIS INTERVERTEBRAL DISC

Model Number	09.820.026S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implant date was sometime in (b)(6) of 2013, exact date is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 patient underwent c5/c6 prodisc-c removal due to continued pain and radicular symptoms.Originally, the patient underwent implantation on, (b)(6) 2013.The patient developed neck pain 2 years after implantation and surgeon offered to remove and fuse.However, the patient decided to go forward with conservative measures, epidural steroid injections, etc.Recently the patient had increased pain and went to the surgeon.Lateral x-ray was taken on an unknown date, and the removal surgery was scheduled on (b)(6) 2019.The implant was successfully explanted and the patient was revised to fusion using medtronic cage and plate.The procedure was successfully completed with no surgical delay.Patient was stable after the procedure.This complaint involves one (1) device.This report is 1 of 1 for (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.Device history records review was completed for part: 09.820.026s, lot: 7039292.Manufacturing location: brandywine, manufacturing date: sep 19, 2012, expiry date: aug 2016.No non conformance reports were generated during production.Review of device history for the product showed that the lot met all dimensional, visual and packaging criteria at the time of release, and there were no non-conformance that would contribute to this complaint.The complaint product was not received.This manufacturing investigation was performed based on photographs of the complaint product.Upon visual inspection on provided photos, it was showing some visual damages/ deformation.It is most likely due to the explantation of the implant.Based on the x-rays, complaint condition of pain/adverse event could not be confirmed.Prodisc-c, 09.820.026s was reviewed for this complaint.The complaint event description did not state any issues or complaints against this prodisc c product itself or indicate that the prodisc c product caused the complaint condition.Therefore, from a manufacturing perspective there are no complaints with this product.As a result, there will be no further investigation, and the complaint is considered not confirmed.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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: PRODISC-C IMPLANT MEDIUM 6MM-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: 8480546
• Report Number: 2939274-2019-57271
• Device Sequence Number: 1781379
• Product Code: MJO
• UDI-Device Identifier: 10705034763736
• UDI-Public: (01)10705034763736
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P070001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/01/2016
• Device Model Number: 09.820.026S
• Device Catalogue Number: 09.820.026S
• Device Lot Number: 7039292
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/11/2019
• Supplement Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 04/03/2019
• Supplement Report FDA Received Date: 04/30/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 37 YR