MAUDE Adverse Event Report: CENTINEL SPINE, LLC PRODISC L INFERIOR END PLATE LARGE 0-STERILE; PROSTHESIS, INTERVERTEBRAL DISC

Model Number	PDL-L-IP00S
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Neuropathy (1983); Pain (1994)
Date of Event	03/31/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An mdr is indicated for this complaint.It was reported that a patient with disease of the spinal cord and secondary scoliosis was implanted with prodisc discs at multiple levels in several surgeries.The patient was experiencing neurological symptoms and pain.Due to poor bone quality, adequate fixation of the prodisc l devices at levels l2-3 and l3-4 was not achieved.On (b)(6) 2026 the implants at those levels were removed and replaced with alif cages.A review of the pdl plate dhrs found no anomalies associated with the complaint.A review of the poly inlay dhrs could not be completed as the part number and lot number were not provided and could not be determined during the course of the investigation.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.Following the removal surgery the implants were returned for device evaluation.The evaluation will be completed by exponent following their approved prodisc l device evaluation protocol.The reports will be released under (b)(4) and (b)(4).Imaging was provided that showed the devices prior to removal.There were no anomalies identified during the complaint investigation.The removals were completed due to patient pain and neurological symptoms which was likely due to inadequate implant fixation which was caused by the patient's poor bone quality related to disease of the spinal cord and secondary scoliosis.The submission is 6 of 6 devices involved in this event.
Event or Problem Description
A male patient with disease of the spinal cord and secondary scoliosis was implanted with prodisc discs at multiple levels in several surgeries.Implantation information is not available at this time.The disc at l5-s1 was previously removed and converted to fusion which failed, additionally the l4-5 posterior fusion failed.The patient was experiencing neurological symptoms and pain.Due to poor bone quality, adequate fixation of the prodisc l devices at levels l2-3 and l3-4 was not achieved.On (b)(6) 2026 the implants at those levels were removed and replaced with alif cages.

• Brand Name: PRODISC L INFERIOR END PLATE LARGE 0-STERILE
• 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: 24931182
• Report Number: 3007494564-2026-00041
• Device Sequence Number: 21514688
• Product Code: MJO
• UDI-Device Identifier: 00843193111692
• UDI-Public: (01)00843193111692(17)280331(10)2022-0089
• 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 Explanted Year: 2026
• 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): 04/20/2026

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: PDL-L-IP00S
• Device Catalogue Number: N/A
• Device Lot Number: 2022-0089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/17/2023
• 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: 49 YR
• Patient Sex: Male