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

Model Number	09.820.056S
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Failure to Osseointegrate (1863)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The information provided by the reporter indicates and confirms an anterior migration of the pdc 6mm implant.The patient suffered an identical problem with a pdc 5mm implant and underwent revision on (b)(6) 2021 which was reported under mdr 3007494564-2021-00002.The replacement device migrated in an identical manner and required a second revision to a fusion.The patient reported no complications or symptoms as a result of either implant migration.There was no indication of comorbidities.The cause of the migration is unknown.The previous complaint indicated the patient fell leading to the migration.No traumatic event was indicated in this complaint.This complaint involves the same patient as 3007494564-2021-00002, but a difference device on a different day.Dhr review was completed without any noted problems in manufacturing.The risk assessment determined migration or loss of plate fixation is a known risk.The risk carries several possible harms though this complaint did not indicate a specific patient harm.The patient was revised to preclude possible harm.The explanted device was retrieved and shipped to exponent for scientific analysis.The device was assigned id: pdc-rd-0023.Analysis is currently in process.If there is evidence from analysis that would change the conclusions of this investigation, a follow up submission will be completed.The prodisc c us surgical technique guide and instructions for use were both reviewed.The review noted a precaution due to the unknown safety and effectiveness of prodisc c in patients with "prior surgery at the level to be treated".This may have been a factor in the migration since this patient was previously implanted with a pdc 5mm implant at the same level.
Event or Problem Description
The patient had previously underwent a revision on (b)(6) 2021 to replace a 5mm pdc implant with a 6mm.The previous 5mm implant was implanted on (b)(6) 2020.The 1st revision was due to a patient fall which caused anterior migration of the prodisc c implant out of the disc space.The patient then suffered another migration of the 6mm pdc implant due to unknown reasons.The patient was revised to a fusion using unknown devices on (b)(6) 2021.The patient did not have any comorbidities or any complications or symptoms as a result of the migration.The imaging from both pdc revision cases indicated the device migrated anteriorly approximately 50% of the implant ap depth.

• Brand Name: PRODISC C US IMPLANT LARGE-DEEP 6MM
• Common Device Name: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): CENTINEL SPINE, LLC.; 900 airport rd, suite 3b; west chester PA 19380
• MDR Report Key: 11440261
• Report Number: 3007494564-2021-00015
• Device Sequence Number: 3539679
• Product Code: MJO
• UDI-Device Identifier: 00843193112859
• UDI-Public: 00843193112859
• 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: 2021
• 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): 03/03/2021

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: 03/31/2022
• Device Model Number: 09.820.056S
• Device Catalogue Number: N/A
• Device Lot Number: H625794
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2021
• Initial Report FDA Received Date: 03/08/2021
• 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: 42 YR