MAUDE Adverse Event Report: SYNTHES BRANDYWINE PRODISC C US IMPLANT MEDIUM 6MM; PROSTHESIS, INTERVERTEBRAL DISC

Model Number	09.820.026S
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that a patient was implanted with a prodisc c device at level c5-6 on (b)(6) 2021.The implant was removed on (b)(6) 2023.No stated reason for removal was provided, x-ray images were provided.A dhr review could not be completed as synthes was the manufacturer of this device and the dhr was not available from them.Complaint trending found that the rate of complaints was within the level defined in the risk documentation.A review of the risk assessment found that the harm associated with the complaint is identified and mitigated to a level where the benefits outweigh the risks.The implant was returned to exponent and will be evaluated under their standard prodisc c device evaluation protocol, report number (b)(4).No indication for the cause of the pdc removal was determined, the complaint investigation outcome is unknown.The submission is 1 of 1 devices involved in this event.
Event or Problem Description
A patient was implanted with a prodisc c device at level c5-6 on (b)(6) 2021.The implant was removed on (b)(6) 2023.No stated reason for removal was provided, x-ray images were provided.

• Brand Name: PRODISC C US IMPLANT MEDIUM 6MM
• Common Device Name: 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: erin ward ; 900 airport road; suite 3b; west chester, PA 19380 ; 4848878894
• MDR Report Key: 17049194
• Report Number: 3007494564-2023-00031
• Device Sequence Number: 6993787
• Product Code: MJO
• UDI-Device Identifier: 10705034763736
• UDI-Public: 10705034763736
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P070001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/31/2023

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: 03/31/2022
• Device Model Number: 09.820.026S
• Device Catalogue Number: N/A
• Device Lot Number: H624418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/05/2023
• Initial Report FDA Received Date: 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female