MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PRODISC-C IMPLANT MEDIUM DEEP 5MM-STERILE; PROSTHESIS INTERVERTEBRAL DISC

Model Number	09.820.035S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arthritis (1723); Pain (1994); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 c4/c5 prodisc-c removal, due to continued patient pain and facet arthrosis.Originally, the patient underwent pdc implantation about 6 years ago.The pdc implant was successfully explanted and the patient was revised to depuy synthes zero-p fusion, stand-alone device.The procedure was successfully completed with no surgical delay.Patient outcome was good.This report is for one (1) prodisc-c implant medium deep 5mm sterile.This is report 1 of 1 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.A device history record (dhr) review was conducted: part number 09.820.035s.Lot number: 6894243.Date of manufacture: 03/14/2012.Place of manufacture: brandywine plant.Part expiration date: 02/2016.The device history record(s) showed that there were no nonconformances or issues during the manufacture of the product that would contribute to this complaint condition.Product was shipped to the vendor for sterilization.The complaint device was not received for investigation.The following investigation is based on the images/x-rays provided.Visual inspection: photos/x-rays of the prodisc-c implant medium deep 5mm-sterile (p/n 09.820.035s lot 6894243) was received showing no implant failure/defect.Conclusion: no device issues were observed during investigation for the prodisc-c implant medium deep 5mm-sterile (p/n 09.820.035s lot 6894243) as the provided x-rays did not show any implant failure/defect.During this investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Concomitant medical products: complainant part is not returned to manufacturer for review/investigation.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 DEEP 5MM-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: 8718847
• Report Number: 2939274-2019-58788
• Device Sequence Number: 2387203
• Product Code: MJO
• UDI-Device Identifier: 10705034763750
• UDI-Public: (01)10705034763750
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P070001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2019

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: 02/01/2016
• Device Model Number: 09.820.035S
• Device Catalogue Number: 09.820.035S
• Device Lot Number: 6894243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2019
• Initial Date Received by Manufacturer: 05/24/2019
• Supplement Date Received by Manufacturer: 07/09/2019
• Initial Report FDA Received Date: 06/20/2019
• Supplement Report FDA Received Date: 07/17/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention