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

Model Number	09.820.036S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient received a prodisc c implant at level c3-4 on (b)(6) 2023.Due to the patient's poor bone quality the surgeon removed the pdc implant on (b)(6) 2023 and performed a corpectomy at the level.Mdr submission was indicated.A review of the dhr was completed and no anomalies associated with the complaint were identified.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 poor bone quality.No other anomalies associated with the complaint were found during the investigation.This report is for 1 of 1 devices involved in this event.
Event or Problem Description
Patient received a prodisc c implant at level c3-4 on (b)(6) 2023.Due to the patient's poor bone quality the surgeon removed the pdc implant on (b)(6) 2023 and performed a corpectomy at the level.

• Brand Name: PRODISC C US IMPLANT MEDIUM-DEEP 6MM
• Common Device Name: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): CENTINEL SPINE; 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, PA 19380 ; 4848878894
• MDR Report Key: 18182433
• Report Number: 3007494564-2023-00064
• Device Sequence Number: 20754945
• Product Code: MJO
• UDI-Device Identifier: 00843193112798
• UDI-Public: 00843193112798
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 11/20/2023

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 Expiration Date: 01/31/2026
• Device Model Number: 09.820.036S
• Device Catalogue Number: UNKNOWN
• Device Lot Number: 2021-1131
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/26/2023
• Initial Report FDA Received Date: 11/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2022
• 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: 56 YR
• Patient Sex: Female