MAUDE Adverse Event Report: CENTINEL SPINE, LLC. PRODISC C US IMPLANT LARGE-DEEP 5MM; PROSTHESIS, INTERVERTEBRAL DISC

Model Number	09.820.055S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Extraskeletal ossification (1428)
Date of Event	05/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A patient was implanted with a prodisc c us large deep 5mm implant at c4/5 disc space on (b)(6) 2020.On an unknown date, the patient was diagnosed with heterotopic ossification limiting the motion at the spinal segment.No further indication of patient conditions or symptoms was provided.There was no indication as to why the ossification had developed.Limited information has been made available from this case.Dhr review did not find any contributory manufacturing issues.Complaint trending determined the rate of complaints is acceptable based on the risk assessment.Risk of heterotopic ossification and/or auto-fusion is an identified risk which has been mitigated and accepted.No device was provided for evaluation.The facility did not provide an explanation as to why the device was not available for retrieval.The investigation could not identify a device problem which may have contributed to the patient's ossification.This submission is for 1 of 1 devices involved in this event.
Event or Problem Description
A patient received a prodisc c us implant at the c4/5 level on (b)(6) 2020.On an unknown date, the patient was diagnosed with heterotopic ossification at the prodisc c level.The patient underwent surgical intervention on (b)(6) 2021 to remove the prodisc c implant and replace it with a synthes zero p cage and screws.

• Brand Name: PRODISC C US IMPLANT LARGE-DEEP 5MM
• Common Device Name: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): CENTINEL SPINE, LLC.; 900 airport rd, suite 3b; west chester PA 19380
• MDR Report Key: 11938766
• Report Number: 3007494564-2021-00048
• Device Sequence Number: 3692829
• Product Code: MJO
• UDI-Device Identifier: 00843193112842
• UDI-Public: 00843193112842
• 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: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/02/2021

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: 06/30/2022
• Device Model Number: 09.820.055S
• Device Catalogue Number: N/A
• Device Lot Number: H686884
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/10/2021
• Initial Report FDA Received Date: 06/04/2021
• 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: 58 YR