MAUDE Adverse Event Report: SYNTHES BRANDYWINE PRODISC L INFERIOR END PLATE MEDIUM 0-STERILE; PROSTHESIS, INTERVERTEBRAL DISC

Model Number	PDL-M-IP00S
Medical Device Problem Code	Expulsion (2933)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/12/2023
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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 3 of 3 devices involved in this event.

• Brand Name: PRODISC L INFERIOR END PLATE MEDIUM 0-STERILE
• 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: 17865593
• Report Number: 3007494564-2023-00052
• Device Sequence Number: 12250562
• Product Code: MJO
• UDI-Device Identifier: 10705034700106
• UDI-Public: 10705034700106
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P050010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2023
• 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): 10/03/2023

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 Model Number: PDL-M-IP00S
• Device Catalogue Number: N/A
• Device Lot Number: 5319353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/03/2023
• 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: Male