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	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A patient received a prodisc c us implant large deep 5mm on (b)(6) 2020.At the patient's 3 month follow up x-ray images revealed the prodisc c device migrated anteriorly out of the disc space.At the time of the follow up appointment the patient did not show any symptoms or complications related to the migrated device.The patient indicated during the follow up appointment they suffered a fall previously but recovered on their own.The fall may have contributed to the migration of the device.The patient then underwent revision and replacement of the prodisc c us implant large deep 5mm with a prodisc c us implant large deep 6mm.The revision was completed without further complications.The patient requested another prodisc device be implanted as a replaced for the previous prodisc c device.Review of the dhr found no manufacturing issues which may have contributed to the event.The risk assessment for the prodisc c device includes risks associated with migration of the device.There were no indications of any new risks of the device.Previous complaints indicate there is a more than remote chance that migration leads to surgical intervention to preclude serious injury.The device was retrieved from the case and will be evaluated by a third party laboratory under the prodisc c retrieval process per the requirements of the prodisc c us pma.
Event or Problem Description
A patient received a prodisc c us implant large deep 5mm on (b)(6) 2020.At the patients 3 month follow up appointment, imaging revealed the prodisc c device migrated anteriorly out of the disc space.At the follow up appointment, the patient did not have any symptoms or complications as a result of the migrated device.The patient informed the surgeon they had suffered a fall previously that may have contributed to the migration of the device.On (b)(6) 2021, the patient underwent revision surgery to replace the 5mm height implant with a prodisc c us implant large deep 6mm.The revision was completed without complications.Patient condition post revision has not been provided.

• 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: 11238113
• Report Number: 3007494564-2021-00002
• Device Sequence Number: 3842405
• 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): 01/25/2021

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: 02/28/2021
• Device Model Number: 09.820.055S
• Device Catalogue Number: N/A
• Device Lot Number: H315928
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/29/2020
• Initial Report FDA Received Date: 01/27/2021
• 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