MAUDE Adverse Event Report: CENTINEL SPINE, LLC PRODISC L INFERIOR END PLATE LARGE 8-STERILE; PROSTHESIS, INTERVERTEBRAL DISC

Model Number	PDL-L-IP08S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	10/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An mdr is indicated for this complaint.It was reported that a patient was implanted with a prodisc l device.It was suspected that the patient had a pars fracture.The implant was removed and the patient fused on (b)(6) 2024.The dhr reviews for the endplates found no anomalies associated with the complaint.A dhr review for the poly inlay could not be completed as the part number and lot number were not provided and could not be determined during the course of the investigation.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 harms associated with the complaint are identified and mitigated to a level where the clinical benefits outweigh the harms.The implant devices were not returned following the removal surgery therefore no device evaluation could be completed.Imaging was not provided.The reason for the removal was due to a possible pars fracture.The submission is 3 of 3 devices involved in this event.
Event or Problem Description
A patient was implanted with a prodisc l device.It was suspected that the patient had a pars fracture.The implant was removed and the patient fused on (b)(6) 2024.

• Brand Name: PRODISC L INFERIOR END PLATE LARGE 8-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): FRUH VERPACKUNGSTECHNIK AG; allmendstrasse 47; fehraltorf, 8320 ; SZ 8320
• Manufacturer Contact: erin ward ; 900 airport road; suite 3b; west chester, PA 19380 ; 4848878894
• MDR Report Key: 20693968
• Report Number: 3007494564-2024-00084
• Device Sequence Number: 17941294
• Product Code: MJO
• UDI-Device Identifier: 00843193114945
• UDI-Public: (01)00843193114945(17)280630(10)2022-1908
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P050010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/14/2024

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-L-IP08S
• Device Catalogue Number: N/A
• Device Lot Number: 2022-1908
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/25/2023
• 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 Sex: Unknown