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

Model Number	PDSXLD5
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/12/2026
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.During the second surgery an sk implant was also placed at c4-5.The patient then had a three level construct of sk devices from c4-7.Approximately two years later the patient had some on-going pain.The surgeon wanted to remove all three devices and fuse the patient.On (b)(6) 2026, the surgeon opened the patient and found that the implant at c6-7 had not fixated and may have been infected.The implants at c4-5 and c5-6 looked good and were left in place.The c6-7 implant was removed and the patient was fused at that level.A dhr review found no anomalies associated with the complaint.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.The sk device was sent to the hospital lab after the removal surgery to the cultured to test for a possible infection.The implant remains in the hospital lab and could not be returned for device evaluation.Additionally, no pre-removal imaging was provided.There were no anomalies identified during the complaint investigation.The removal was completed due to implant loosening.The submission is 1 of 1 devices involved in this event.
Event or Problem Description
A patient, (39-year-old 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.During the second surgery an sk implant was also placed at c4-5.The patient then had a three level construct of sk devices from c4-7.Approximately two years later the patient had some on-going pain.The surgeon wanted to remove all three devices and fuse the patient.On (b)(6) 2026, the surgeon opened the patient and found that the implant at c6-7 had not fixated and may have been infected.The implants at c4-5 and c5-6 looked good and were left in place.The c6-7 implant was removed and the patient was fused at that level.The sk device was sent for cultures and the patient was prescribed oral antibiotics.The patient is doing well postoperatively.

• Brand Name: PRODISC C SK, EXTRA 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: 24764827
• Report Number: 3007494564-2026-00032
• Device Sequence Number: 9299381
• Product Code: MJO
• UDI-Device Identifier: 00843193114006
• UDI-Public: (01)00843193114006(17)280630(10)2022-1858
• Combination Product (Y/N): N
• Initial Reporter State: WY
• 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: 2026
• 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): 04/01/2026

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
• Device Model Number: PDSXLD5
• Device Catalogue Number: N/A
• Device Lot Number: 2022-1858
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/18/2023
• 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: 38 YR
• Patient Sex: Female