MAUDE Adverse Event Report: CENTINEL SPINE, LLC PRODISC C VIVO US IMPLANT XL 5MM; PROSTHESIS, INTERVERTEBRAL DISC

Model Number	PDVXL5
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Neck Pain (2433)
Date of Event	10/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that a patient was implanted with two prodisc c vivo implants at levels c3-4 and c6-7 on (b)(6) 2023.Patient may have had a slip and fall trauma that resulted in a fracture in the device.This lead to increased neck pain with kyphosis postering.The implant was removed (b)(6) 2023 and replaced with a cage and plate system.Complaint trending found that the rate of complaints is within the poc level defined within the risk documentation.A review of the risk documentation found that the hazards associated with this complaint are identified and mitigated to a level where the benefits outweigh the risks.The implant was returned to exponent for third party device evaluation.Exponent will complete the evaluation based upon their approved report protocols.It was confirmed that a removal took place due to an implant fracture that was caused by patient trauma.No other anomalies associated with the complaint were found during the investigation.The submission is 2 of 2 devices involved in this event.
Event or Problem Description
Patient was implanted with two prodisc c vivo implants at levels c3-4 and c6-7 on (b)(6) 2023.Patient may have had a slip and fall trauma that resulted in a fracture in the device.This lead to increased neck pain with kyphosis postering.The implant was removed (b)(6) 2023 and replaced with a cage and plate system.

• Brand Name: PRODISC C VIVO US IMPLANT XL 5MM
• Common Device Name: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): CENTINEL SPINE, LLC; 900 airport road, suite 3b; west chester PA 19380
• Manufacturer (Section G): FRUH VERPACKUNGSTECHNIK AG; allmendstrasse 47; fehraltorf, 8320 ; SZ 8320
• Manufacturer Contact: erin ward ; 900 airport road; suite 3b; west chester
• MDR Report Key: 17994670
• Report Number: 3007494564-2023-00058
• Device Sequence Number: 17705862
• Product Code: MJO
• UDI-Device Identifier: 00843193113795
• UDI-Public: 00843193113795
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P070001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/20/2023

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 Model Number: PDVXL5
• Device Catalogue Number: N/A
• Device Lot Number: 2021-1034R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2023
• Initial Report FDA Received Date: 10/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male