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

Model Number	PDSL5
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	01/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was implanted with a prodisc c sk device at c5-6 on (b)(6) 2023.The tdr level was reported as being hyper mobile and causing pain, surgeon stated that the patient seemed to never quite heal and that the implant seemed loose upon removal.The surgeon removed the sk implant and fused the patient on (b)(6) 2025.Surgeon sent the patient for serological allergy screening post removal and fusion to rule out any unreported metal allergies and the results confirmed that the patient has a previously undiagnosed low grade nickel allergy which the surgeon believes caused the need to explant the sk.
Additional Manufacturer Narrative
An mdr is indicated for this complaint.It was reported that a patient was implanted with a prodisc c sk device at c5-6 on (b)(6) 2023.The tdr level was reported as being hyper mobile and causing pain, surgeon stated that the patient seemed to never quite heal and that the implant seemed loose upon removal.The surgeon removed the sk implant and fused the patient on (b)(6) 2025.Surgeon sent the patient for serological allergy screening post removal and fusion to rule out any unreported metal allergies and the results confirmed that the patient has a previously undiagnosed low grade nickel allergy which the surgeon believes caused the need to explant the sk.A review of the dhr 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 hazards associated with the complaint are identified and mitigated to a level where the clinical benefits outweigh the harms.There are no previous issues or capas associated with the complaint.A device evaluation could not be completed as the implant was not returned following the removal surgery and no imaging was provided.The surgeon did confirm that the patient had a previously undiagnosed low grade nickel allergy.The removal was due to the patient's nickel allergy.The submission is 1 of 1 devices involved in this event.

• Brand Name: PRODISC C SK, LARGE, 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: 21424076
• Report Number: 3007494564-2025-00026
• Device Sequence Number: 20811611
• Product Code: MJO
• UDI-Device Identifier: 00843193113917
• UDI-Public: (01)00843193113917(17)280331(10)2022-1364
• 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: 2023
• Device Explanted Year: 2025
• 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): 02/20/2025

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: PDSL5
• Device Catalogue Number: UNKNOWN
• Device Lot Number: 2022-1364
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 02/20/2025
• 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: 61 YR
• Patient Sex: Female