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 01/01/2023

Event Type  Injury  

Manufacturer Narrative

It was reported that the surgeon indicated that he had a recent retrieval case for a prodisc l device where the poly inlay had expulsed post-operatively.No other information was provided.An mdr and mir report were both indicated for this complaint.A review of the dhrs could not be completed as synthes was the manufacturer of these implants and the dhrs could not be located at this time.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 clinical benefits outweigh the surgical risks.Device evaluation could not be completed as the implant was not released from the hospital.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 3 of 3 devices involved in this event.

Event Description

Surgeon indicated the he had a recent retrieval case for a pdl device where the inlay had expulsed post operatively.

• 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
• MDR Report Key: 18218754
• MDR Text Key: 329144033
• Report Number: 3007494564-2023-00068
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2023
• 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?: No
• Date Manufacturer Received: 11/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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