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

Model Number 09.820.026S

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 05/12/2023

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 316392333
• Report Number: 3007494564-2023-00031
• Device Sequence Number: 1
• Product Code: MJO
• UDI-Device Identifier: 10705034763736
• UDI-Public: 10705034763736
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 05/05/2023
• Initial Date FDA Received: 06/02/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female