MAUDE Adverse Event Report: CENTINEL SPINE, LLC. PRODISC C TOTAL DISC REPLACEMENT; PROTHESIS, INTERVERTEBRAL DISC

Model Number	09.820.066S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Neck Pain (2433)
Date of Event	09/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2020 a patient had a prodisc c device explanted and replaced with an m6 cage.The prodisc c device was explanted due to patient pain.The source of the pain is unknown thus a conservative assumption that the prodisc c device may be contributing was made.It was also assumed the surgical intervention performed was to preclude permanent impairment and/or pain thus a report was required.Dhr review did not find any anomalies in manufacturing.The rate of complaints was determined to be acceptable when evaluated against the device risk assessment.The associated risks have been identified, mitigated, and accepted based on the device dfmea.The device was not made available for retrieval and analysis for unknown reasons.The investigation could not determine a cause for this complaint.
Event or Problem Description
On (b)(6) 2020 a patient underwent revision surgery to explant a prodisc c implant and replace it with an m6 cage.The prodisc c device was removed due to patient pain of unknown source.A conservative assumption suggests the prodisc c device may have been contributing to the pain and need for removal to preclude a permanent injury.

• Brand Name: PRODISC C TOTAL DISC REPLACEMENT
• Common Device Name: PROTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): CENTINEL SPINE, LLC.; 900 airport rd, suite 3b; west chester PA 19380
• MDR Report Key: 10685504
• Report Number: 3007494564-2020-00043
• Device Sequence Number: 436792
• Product Code: MJO
• UDI-Device Identifier: 00843193112880
• UDI-Public: 00843193112880
• 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: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/14/2020

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: 10/31/2020
• Device Model Number: 09.820.066S
• Device Catalogue Number: N/A
• Device Lot Number: H220052
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/15/2020
• Initial Report FDA Received Date: 10/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR