MAUDE Adverse Event Report: SYNTHES BRANDYWINE PRODISC C IMPLANT MED 5MM; PROSTHESIS, INTERVERTEBRAL DISC

Model Number	UNKNOWN
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hyperextension (4523)
Date of Event	09/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An mdr is indicated for this complaint.It was reported that a patient was implant with a prodisc c implant at c4-5, no information is known about the implantation.Patient was experiencing hypermobility and the surgeon removed the implant and fused the patient on (b)(6) 2024.A dhr review could not be completed as the part number and lot number were not provided and could not be determined during the course of the complaint investigation.Complaint trending found that the rate of complaints is within the level outlined in the risk documentation.A review of the risk assessment found that the harms associated with the complaint are identified and mitigated to a level where the clinical benefits outweigh the risks.The removed implants will be evaluated following exponent's approved prodisc c device evaluation protocol.The report will be issued under pdc-rd-0064.Pre-removal imaging was provided.The removal was due to the patient's hypermobility.The submission is 1 of 1 devices involved in this event.
Event or Problem Description
A patient was implant with a prodisc c implant at c4-5, no information is known about the implantation.Patient was experiencing hypermobility and the surgeon removed the implant and fused the patient on (b)(6) 2024.

• Brand Name: PRODISC C IMPLANT MED 5MM
• 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: 20441413
• Report Number: 3007494564-2024-00077
• Device Sequence Number: 8090604
• Product Code: MJO
• UDI-Device Identifier: 10705034763729
• UDI-Public: (01)10705034763729
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P070001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/10/2024

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 Model Number: UNKNOWN
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/17/2024
• Initial Report FDA Received Date: 10/14/2024
• 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 Sex: Unknown