MAUDE Adverse Event Report: SYNTHES BRANDYWINE PRODISC L POLY INLAY; PROSTHESIS, INTERVERTEBRAL DISC

Model Number UNKNOWN

Device Problem Expulsion (2933)

Patient Problem Insufficient Information (4580)

Event Date 09/12/2023

Event Type  Injury  

Event Description

Patient received a prodisc l device on (b)(6) 2009 due to degenerative disc disease at l4-5.It was found that the poly had displaced anteriorly.The pdl was removed on (b)(6) 2023 and the patient converted to an alif.Pre-removal imaging was provided.

Manufacturer Narrative

It was reported that a patient received a prodisc l device on (b)(6) 2009 due to degenerative disc disease at l4-5.It was found that the poly had displaced anteriorly.The pdl was removed on (b)(6) 2023 and the patient converted to an alif.Pre-removal imaging was provided.Complaint trending found that the rate of complaints is within the poc level defined within the risk documentation.A review of the risk documentation found that the hazard associated with this complaint is identified and mitigated to a level where the benefits outweigh the risks.Device evaluation will be completed by exponent under pdl-rd-0011 using their standard pdl evaluation procedure.It was confirmed that a revision took place due to poly inlay expulsion.No other anomalies associated with the complaint were found during the investigation.This submission is 2 of 3 devices involved in this event.

• Brand Name: PRODISC L POLY INLAY
• 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: 17865576
• MDR Text Key: 324864972
• Report Number: 3007494564-2023-00051
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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: 09/20/2023
• Date Manufacturer Received: 09/06/2023
• 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: Male