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

Model Number	09.820.035S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The information provided by the reporter indicates a patient has suffered an anterior migration of a prodisc c implant in the c5/6 disc space.There has been no indication of patient symptoms as a result of the migration.The patient underwent revision surgery on (b)(6) 2021 which is believed to have precluded serious injury based on previous complaints.There was no indication of patient comorbidities or pre-existing conditions.The information provided did not suggest a reason or cause for the anterior migration of the implant.No complications were reported from the removal procedure.The prodisc c device was replaced with a fusion using unknown devices.Dhr review did not find any problems during manufacturing which may have contributed to the event.The risk assessment determined the risks associated with migration of the implant are identified and the rate of complaints was acceptable.There has been no confirmation that the device was available for retrieval.No explanation was provided despite follow up requests to have the explanted device returned for evaluation.The investigation could not determine a cause for the implant migration.This submission is for 1 of 1 devices involved in this event.
Event or Problem Description
Patient received a prodisc c us implant medium deep 5mm on (b)(6) 2021 in the c5/6 disc space.Follow up imaging revealed the prodisc c device migrated anteriorly.Lateral x-rays provided confirm this reported malfunction.The patient was scheduled for removal to preclude serious injury.There was no indication of patient complications or symptoms.There were no reported comorbidities or pre-existing conditions.On (b)(6)2021 the prodisc c device was removed and converted to a fusion.There were no indications of complications during the removal procedure.

• Brand Name: PRODISC C US IMPLANT MEDIUM 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: 12526721
• Report Number: 3007494564-2021-00082
• Device Sequence Number: 4231620
• Product Code: MJO
• UDI-Device Identifier: 00843193112781
• UDI-Public: 00843193112781
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P070001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 09/21/2021

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: 09/30/2021
• Device Model Number: 09.820.035S
• Device Catalogue Number: N/A
• Device Lot Number: H332687
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2021
• Initial Report FDA Received Date: 09/24/2021
• 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: 41 YR