MAUDE Adverse Event Report: CENTINEL SPINE, LLC. PRODISC C SK, MEDIUM DEEP, 7MM; PROSTHESIS, INTERVERTEBRAL DISC

Model Number	PDSMD7
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	02/19/2026
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 two pdc sk devices at c5-6 and c6-7 on (b)(6) 2024.Patient had lingering pain and the surgeon was concerned about a possible infection.An exploratory revision surgery was scheduled.There were no visible signs of infection but the patient had poor bone quality.C6-7 was removed and the area swabbed for cultures, during the removal surgery the surgeon decided to remove the c5-6 level as well.The sk devices were replaced with cages and then the patient was closed and flipped and posterior fixation was added.A review of the dhrs 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 pdc sk implants were returned for device evaluation following the removal surgery and will be evaluated using exponent's approved prodisc c evaluation protocol.The reports will be issued under pdcs-0010 and pdcs-0011.No pre-removal imaging was provided.There were no anomalies identified during the complaint investigation.The removal was completed due to ongoing pain.The submission is 2 of 2 devices involved in this event.
Event or Problem Description
A patient (55 years, female) was implanted with two pdc sk devices at c5-6 and c6-7 on (b)(6) 2024.Patient had lingering pain and the surgeon was concerned about a possible infection.An exploratory revision surgery was scheduled.There were no visible signs of infection but the patient had poor bone quality.C6-7 was removed and the area swabbed for cultures, during the removal surgery the surgeon decided to remove the c5-6 level as well.The sk devices were replaced with cages and then the patient was closed and flipped and posterior fixation was added.Patient was given oral antibiotics to start while waiting for cultures to be returned.

• Brand Name: PRODISC C SK, MEDIUM DEEP, 7MM
• 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, 8320 ; SZ 8320
• Manufacturer Contact: erin ward ; 900 airport road; suite 3b; west chester, PA 19380 ; 4848878894
• MDR Report Key: 24532157
• Report Number: 3007494564-2026-00012
• Device Sequence Number: 13349818
• Product Code: MJO
• UDI-Device Identifier: 00843193113900
• UDI-Public: (01)00843193113900(17)270831(10)2022-1483
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 03/02/2026

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: PDSMD7
• Device Catalogue Number: N/A
• Device Lot Number: 2022-1483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/06/2022
• 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: 55 YR
• Patient Sex: Female