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

Model Number	PDSLD5
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/11/2024
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 two prodisc c sk devices at c5-6 and c6-7 on (b)(6) 2024.Three months later, on (b)(6) 2024, the patient had a removal of the c5-6 sk implant, which was replaced by a second sk implant on a larger height.A review of the dhr found 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 hazards associated with the complaint are identified and mitigated to a level where the clinical benefits outweigh the harms.The implant was removed in april 2024 and was not returned following the removal surgery.Therefore, no device evaluation could be completed.Additionally, no imaging was provided.There were no anomalies identified during the complaint investigation.The removal was completed due to the implant being undersized.The submission is 1 of 1 devices involved in this event.
Event or Problem Description
A patient (39 yo female) was implanted with a two prodisc c sk devices at c5-6 and c6-7 on (b)(6) 2024.Three months later, on (b)(6) 2024, the patient had a removal of the c5-6 sk implant, which was replaced by a second sk implant on a larger height.This removal was identified during the investigation of (b)(4), which was a recent removal completed on the same patient.

• 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, che 8320 ; SZ 8320
• Manufacturer Contact: erin ward ; 900 airport road; suite 3b; west chester, PA 19380 ; 4848878894
• MDR Report Key: 25027920
• Report Number: 3007494564-2026-00042
• Device Sequence Number: 13295297
• Product Code: MJO
• UDI-Device Identifier: 00843193113948
• UDI-Public: (01)00843193113948(17)280630(10)2023-0099
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/28/2026

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: 2023-0099
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/26/2023
• 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: 36 YR
• Patient Sex: Female