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

Model Number	PDSXL5
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An mdr is indicated for this complaint.It was reported that a patient was implanted with two prodisc c sk devices on (b)(6) 2026.Both implants were labeled as 5mm devices but once placed it was evident that one implant was taller than the other.The surgeon stated that the implant height is fine and that the patient could take a 5 or 6mm device.A review of the dhr found no anomalies associated with the complaint, however, an investigation found that this lot of implants was assembled with poly inlays that were 6mm in height instead of 5mm in height.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 this complaint are identified and mitigated to a level where the clinical benefits outweigh the harms.The sk device remains implanted in the patient and was not returned; therefore, no evaluation could be completed.Imaging was provided that shows the height difference between the two sk devices that were implanted within the patient.The investigation found that the mislabeling of the implant was due to a supplier manufacturing issue.The submission is 1 of 1 devices involved in this event.
Event or Problem Description
A patient (20yo, male) was implanted with two prodisc c sk devices on (b)(6) 2026.Both implants were labeled as 5mm devices but once placed it was evident that one implant was taller than the other.Investigation found that the one implant was 6mm but labeled as 5mm.The surgeon stated to leave the implant alone.He said the height is fine and that the patient could take a 5 or 6mm device.He said he would have pulled it out if he thought it would hurt the patient.

• Brand Name: PRODISC C SK, EXTRA 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 EXTON; 240 sierra drive; exton PA 19341
• Manufacturer Contact: erin ward ; 900 airport road; suite 3b; west chester, PA 19380 ; 4848878894
• MDR Report Key: 24715993
• Report Number: 3007494564-2026-00030
• Device Sequence Number: 20278079
• Product Code: MJO
• UDI-Device Identifier: 00843193113979
• UDI-Public: (01)00843193113979(17)301231(10)2026-0026
• 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: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 03/26/2026

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: PDSXL5
• Device Catalogue Number: N/A
• Device Lot Number: 2026-0026
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2026
• 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: 20 YR
• Patient Sex: Male