MAUDE Adverse Event Report: CENTINEL SPINE, LLC. PRODISC C SK, LARGE, 6MM; PROSTHESIS, INTERVERTEBRAL DISC

Model Number	PDSL6
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Pain (1994)
Date of Event	01/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An mdr is indicated for this complaint.It was reported that a patient was implanted with a pdc sk device at c5-6 on (b)(6) 2025.This implant was identified as one of the lot that was labeled as a 6mm height but was assembled as a 5mm height.At a follow-up appointment the patient reported right hand weakness and surgical site irritation.Imaging found that the implant is kyphotic.Surgeon reported that the patient has <1mm range of motion due to the kyphosis.If the patient's symptoms do not resolve the implant will be revised.A dhr review found no anomalies identified during the complaint, however, this lot has been identified as having an overall implant height that does not match the labeling of the device.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 pdc sk device remains implanted in the patient and therefore is not available for evaluation.Imaging was provided that shows the device is kyphotic.The patient's symptoms may be caused by the kyphotic implant.The implant may have moved post-operatively which could have caused the kyphosis.There is a known manufacturing issue with this lot but it is currently unknown if this is what led to the kyphotic implant.The doctor is following up with the patient and this complaint will be updated if there is a change to the outcome.The submission is 1 of 1 devices involved in this event.
Event or Problem Description
A patient (49yo, female) was implanted with a pdc sk device at c5-6 on (b)(6) 2025.This implant was identified as one of the lot that was labeled as a 6mm height but was assembled as a 5mm height.This lot is under a fsca.At the (b)(6) 2025 follow-up the patient reported overall improvement of 80% and still had some spasms and mild pain with extension.At the (b)(6) 2026 follow up the patient reported right hand weakness and surgical site irritation, the patient felt like they were regressing.Imaging found that the implant is kyphotic.Surgeon reported that the patient has <1mm range of motion due to the kyphosis.If the patient's symptoms do not resolve the implant will be revised.

• Brand Name: PRODISC C SK, LARGE, 6MM
• 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 EXTON; 240 sierra drive; exton PA 19341
• Manufacturer Contact: erin ward ; 900 airport road; suite 3b; west chester, PA 19380 ; 4848878894
• MDR Report Key: 24318060
• Report Number: 3007494564-2026-00008
• Device Sequence Number: 4863400
• Product Code: MJO
• UDI-Device Identifier: 00843193113924
• UDI-Public: (01)00843193113924(17)300630(10)2025-0776
• 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: 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): 02/11/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PDSL6
• Device Catalogue Number: N/A
• Device Lot Number: 2025-0776
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/31/2025
• 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
• Patient Age: 49 YR
• Patient Sex: Female