MAUDE Adverse Event Report: CENTINEL SPINE, LLC PRODISC L PE-INLAY W/ X-RAY MARKER, STERILE, SIZE MEDIUM, 10MM; PROSTHESIS, INTERVERTEBRAL DISC

Model Number	PDL-M-PT10S
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/14/2024
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 at l5/s1 on (b)(6) 2024.The device was removed on (b)(6) 2024.No reason for removal was provided.A review of the dhrs found no anomalies associated with the complaint.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 an acceptable level.The removed implant will be evaluated following exponent's approved prodisc l device evaluation protocol.The report will be issued under pdl-rd-0015.No imaging was provided.A prodisc l removal occurred, but the reason for the removal is unknown.This report is for 2 of 3 devices in this event.
Event or Problem Description
It was reported that a patient was implanted with a prodisc l device at l5/s1 on (b)(6) 2024.The device was removed on (b)(6) 2024.No reason for removal was provided.

• Brand Name: PRODISC L PE-INLAY W/ X-RAY MARKER, STERILE, SIZE MEDIUM, 10MM
• 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: 20893679
• Report Number: 3007494564-2024-00093
• Device Sequence Number: 18352650
• Product Code: MJO
• UDI-Device Identifier: 00843193111760
• UDI-Public: (01)00843193111760(17)281231(10)2023-1102
• 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 Implanted Year: 2024
• 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): 12/09/2024

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-M-PT10S
• Device Catalogue Number: N/A
• Device Lot Number: 2023-1102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/05/2024
• 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