MAUDE Adverse Event Report: CENTINEL SPINE, LLC PRODISC L INFERIOR END PLATE MEDIUM 0-STERILE; PROSTHESIS, INTERVERTEBRAL DISC

Model Number	PDL-M-IP00S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient was implanted with a prodisc l implant at l5-s1 on (b)(6) 2019.Patient experienced instability at the level due to a bilateral pars fracture.The pdl implant was removed and the patient was fused on (b)(6) 2025.
Additional Manufacturer Narrative
An mdr is indicated for this complaint.It was reported that a patient was implanted with a prodisc l implant at l5-s1 on (b)(6) 2019.Patient experienced instability at the level due to a bilateral pars fracture.The pdl implant was removed and the patient was fused on (b)(6) 2025.A review of the dhrs could not be completed as synthes was the legal manufacturer of the implants and the dhrs were not available from them for review.Complaint trending found that the rate of complaints is within the level outlined in the risk documentation.A review of the risk documentation found that the hazards associated with the complaint are identified and mitigated to a level where the clinical benefits outweigh the risks.A device evaluation could not be completed as the devices were not returned following the removal surgery.Pre-removal imaging showing the pars fracture was not provided.The removal was completed due to a bilateral pars fracture, a reason for the fracture is unknown.The 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): CENTINEL SPINE, LLC; 900 airport road, suite 3b; 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: 21273796
• Report Number: 3007494564-2025-00018
• Device Sequence Number: 8080153
• Product Code: MJO
• UDI-Device Identifier: 10705034700106
• UDI-Public: (01)10705034700106(10)H423719
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P050010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2025
• 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): 01/29/2025

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: H423719
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 01/30/2025
• 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: 49 YR
• Patient Sex: Unknown