MAUDE Adverse Event Report: CENTINEL SPINE, LLC PRODISC L UNKNOWN INFERIOR ENDPLATE; PROSTHESIS, INTERVERTEBRAL DISC

Model Number	UNKNOWN
Medical Device Problem Code	Expulsion (2933)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2026
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 prodisc l device approximately 15 years ago.The patient followed up with the implantation surgeon after experiencing increased lower back pain while squatting.Imaging was reviewed and it was determined that the poly inlay was expulsed.A dhr review could not be completed as the part numbers and lot numbers 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 outline 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 pdl device remains implanted within the patient therefore no device evaluation was completed at this time.Imaging was provided that showed the expulsed poly inlay.There were no anomalies identified during the course of the complaint investigation.A reason for the poly inlay expulsion is unknown.This submission is 3 of 3 devices involved in this event.
Event or Problem Description
A patient was implanted with a prodisc l device approximately 15 years ago.The patient followed up with the implantation surgeon after experiencing increased lower back pain while squatting.Imaging was reviewed on a peer-to-peer discussion it was determined that the poly inlay was expulsed or expulsing.The patient is asymptomatic and this was considered an ancillary radiographic finding.Surgeon was going to discuss possible medical or surgical interventions with the patient.At this time no intervention has been scheduled.

• Brand Name: PRODISC L UNKNOWN INFERIOR ENDPLATE
• Common Device Name: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): CENTINEL SPINE, LLC; 900 airport road; suite 3b; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: erin ward ; 900 airport road; suite 3b; west chester, PA 19380 ; 4848878894
• MDR Report Key: 25171582
• Report Number: 3007494564-2026-00052
• Device Sequence Number: 18676584
• Product Code: MJO
• UDI-Device Identifier: 10705034700182
• UDI-Public: (01)10705034700182
• 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 Implanted Year: 2011
• 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): 05/13/2026

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: UNKNOWN
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown