MAUDE Adverse Event Report: CENTINEL SPINE, LLC PRODISC C SK, LARGE DEEP, 5MM; PROSTHESIS, INTERVERTEBRAL DISC

Model Number	PDSLD5
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	08/21/2024
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 c sk implant at level c4-5 on (b)(6) 2024.The patient had continuous neck pain and lots of scar tissue.No malfunction or defect was seen with the sk implant.The surgeon made the decision to remove the implant and fuse the patient.The implant was removed on (b)(6) 2024.A dhr review revealed no anomalies associated with the complaint.Complaint trending found that the rate of complaints is within the level defined 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 benefit outweighs the risks.The implant was not returned following the removal surgery; therefore, no device evaluation could be completed.In addition, no pre-removal imaging was provided.The implant was removed due to ongoing pain, the reason for the pain is unknown.The submission is 1 of 1 devices involved in this event.
Event or Problem Description
It was reported that a patient was implanted with a prodisc c sk implant at level c4-5 on (b)(6) 2024.The patient had continuous neck pain and lots of scar tissue.No malfunction or defect was seen with the sk implant.The surgeon made the decision to remove the implant and fuse the patient.The implant was removed on (b)(6) 2024.

• Brand Name: PRODISC C SK, LARGE DEEP, 5MM
• 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: 20195429
• Report Number: 3007494564-2024-00072
• Device Sequence Number: 12482521
• Product Code: MJO
• UDI-Device Identifier: 00843193113948
• UDI-Public: 00843193113948
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P070001
• 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): 09/11/2024

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: PDSLD5
• Device Catalogue Number: N/A
• Device Lot Number: 2022-1569
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2024
• Initial Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/19/2023
• 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 Age: 58 YR
• Patient Sex: Male