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

Model Number	PDSMD5
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Limb Pain (4836)
Date of Event	10/01/2024
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 prodisc c sk device on (b)(6) 2024 at the c5-6 level.Patient was experiencing recurring radicular pain on the other side of the body from the initial surgery.It was found that the device may have been undersized and tilting to one side, leading to the patient's symptoms.The surgeon removed the implant on (b)(6) 2024 and fused the patient with a plate and cage system.A dhr review revealed no anomalies associated with the complaint.Complaint trending found that the rate of complaints is within the level defined in the risk documentation.A review of the risk documentation found that the harms associated with the complaint are identified and mitigated to a level where the clinical benefit outweighs the risks.The removed implants will be evaluated following exponent's approved prodisc c device evaluation protocol.The report will be issued under pdcs-0004.Additionally, imaging was provided that showed the implant tilting to one side.The removal was completed due to ongoing pain that was likely caused by an undersized implant that was tilting.The submission is 1 of 1 devices involved in this event.
Event or Problem Description
A patient was implanted with a prodisc c sk device on (b)(6) 2024 at the c5-6 level.Patient was experiencing recurring radicular pain on the other side of the body from the initial surgery.It was found that the device may have been undersized and tilting to one side, leading to the patient's symptoms.The surgeon removed the implant on (b)(6) 2024 and fused the patient with a plate and cage system.

• Brand Name: PRODISC C SK, MEDIUM 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, 8320 ; SZ 8320
• Manufacturer Contact: erin ward ; 900 airport road; suite 3b; west chester, PA 19380 ; 4848878894
• MDR Report Key: 20480393
• Report Number: 3007494564-2024-00080
• Device Sequence Number: 15495417
• Product Code: MJO
• UDI-Device Identifier: 00843193113887
• UDI-Public: (01)00843193113887(17)250531(10)2020-0627R
• 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: 2024
• Device Explanted Year: 2024
• 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): 10/17/2024

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 Expiration Date: 05/31/2025
• Device Model Number: PDSMD5
• Device Catalogue Number: N/A
• Device Lot Number: 2020-0627R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/01/2024
• Initial Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/27/2023
• 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: 31 YR
• Patient Sex: Female