MAUDE Adverse Event Report: CENTINEL SPINE, LLC. PRODISC C US IMPLANT 6MM; PROTHESIS, INTERVERTEBRAL DISC

Model Number	09.820.026S
Medical Device Problem Codes	Appropriate Device Problem Term/Code Not Available (3191); Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Neck Pain (2433)
Date of Event	11/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The information provided from the revising surgeons indicates that the pdc device implanted into the c5-6 disc space subsided into the c5 vertebrae.The subsidence is believed to have led to migration of the pdc implant.This also resulted in patient neck and arm pain.The revising surgeon indicated the placement of the pdc retainer screw may have been too close to the intended keel position during implantation.He believes the keel may have collapsed into the hole left behind by the screw.This may have led to the subsidence and migration of the superior endplate.The surgeon decided that a revision and replacement of the pdc device was needed based on the patient's symptoms.Dhr review did not identify any manufacturing anomalies that may have contributed.The risk assessment identified migration and subsidence as possible hazards with pain being a possible harm.There were no indications of new risks based on the information provided.Complaint history review found the rate of complaints to be within allowable limits based on the risk assessment.The device was not made available for evaluation by the hospital.A review of the prodisc c us surgical technique guide was completed.It was noted in the review that the stg advises placement of the pdc retainer screws in the distal 1/3 of the adjacent vertebral bodies to allow adequate room for keel preparation and implant insertion.
Event or Problem Description
A patient underwent a prodisc c removal procedure on (b)(6) 2020 due to implant subsidence and migration.The superior endplate subsided into the c5 vertebrae and migrated anteriorly.The patient expressed neck and arm pain which led to the surgeon's decision to explant the prodisc c and replace it with a 3d printed cage and plate.

• Brand Name: PRODISC C US IMPLANT 6MM
• Common Device Name: PROTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): CENTINEL SPINE, LLC.; 900 airport rd, suite 3b; west chester PA 19380
• MDR Report Key: 10969561
• Report Number: 3007494564-2020-00052
• Device Sequence Number: 2322756
• Product Code: MJO
• UDI-Device Identifier: 00843193112767
• UDI-Public: 00843193112767
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 12/07/2020

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: 06/30/2022
• Device Model Number: 09.820.026S
• Device Catalogue Number: N/A
• Device Lot Number: H697227
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2020
• Initial Report FDA Received Date: 12/08/2020
• 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: 33 YR