MAUDE Adverse Event Report: CENTINEL SPINE, LLC. PRODISC C US IMPLANT MEDIUM-DEEP 6MM; PROSTHESIS, INTERVERTEBRAL DISC

Model Number	09.820.036S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Neck Pain (2433); Vertebral Fracture (4520)
Date of Event	10/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The information provided indicates that a patient suffered subsidence and c5 vertebral body fracture approximately 2 years post op.The patient has a 2-level pdc implantation.The patient has been experiencing pain since july 2021 with no reported traumatic event or fall.There has been no indication why the subsidence and fracture have occurred.X-rays at 2 year follow up showed subsidence.The surgeon then ordered ct scans of the patient which confirmed the subsidence and vertebral body fracture.The c5/6 prodisc c device appears to be in a state of lateral impingement due to the vertebral body fracture.There is no indication how or why these injuries occurred.There was no indication of patient comorbidities.Dhr review did not identify any manufacturing issues which may have contributed to the complaint.Complaint history found the rates of complaints to be acceptable.The risk assessment determined the related risks were identified within the design fmea.No device was returned.The devices remain implanted in the patient with no indication of a scheduled revision surgery.The investigation could not determine a cause for this complaint.There was no clear indication why the patient's injuries have occurred.The cause for this complaint is unknown.This report is for 1 of 2 devices involved in this event.
Event or Problem Description
A patient reported neck pain symptoms at a 2 year follow up appointment.The pain started around (b)(6) 2021.This case is a 2 level prodisc c at c5-6 and c6-7 implanted on (b)(6) 2019.X-rays appear to show the superior endplate of the c5-6 prodisc implant have subsided into the vertebral body and a confirmed split of the c5 vertebral body.The surgeon ordered a ct scan to confirm the c5 fracture.The reporter provided the scan and confirmed that c5 has fractured.The split in the midline of the c5 vertebral body is evident on the ct scan images.The patient did say she was not in an accident and did not fall when asked.Ct scans were performed after initial follow up visit.No indication of revision/removal surgery or other treatment.The c5/6 prodisc c implant appears to be in lateral impingement.

• Brand Name: PRODISC C US IMPLANT MEDIUM-DEEP 6MM
• Common Device Name: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): CENTINEL SPINE, LLC.; 900 airport rd, suite 3b; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: jason smith ; 900 airport rd, suite 3b; west chester, PA 19380 ; 4848878810
• MDR Report Key: 12851384
• Report Number: 3007494564-2021-00105
• Device Sequence Number: 11959149
• Product Code: MJO
• UDI-Device Identifier: 00843193112798
• UDI-Public: 00843193112798
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P070001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 11/19/2021

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: 10/31/2021
• Device Model Number: 09.820.036S
• Device Catalogue Number: N/A
• Device Lot Number: H505747
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 11/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2017
• 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: Other
• Patient Age: 29 YR
• Patient Sex: Female