MAUDE Adverse Event Report: CENTINEL SPINE PRODISC C VIVO US IMPLANT LARGE-DEEP 5MM; PROSTHESIS, INTERVERTEBRAL DISC

Model Number	PDVLD5
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Limb Pain (4836)
Date of Event	11/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient received a prodisc c implant on (b)(6) 2023 at level c6/7.Following surgery, patient had persistent arm pain, patient was revised to a fusion with a camber stand alone cervical cage on (b)(6) 2023.No device malfunction was indicated.An mdr is indicated for this complaint.A review of the dhr identified no anomalies.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.Device evaluation will be completed by exponent following their approved prodisc c device evaluation protocol.It was confirmed that a removal took place due to ongoing patient arm pain.A device malfunction was not indicated and no reason for the arm pain could be determined.The submission is 1 of 1 devices involved in this event.
Event or Problem Description
It was reported that an impromptu prodisc c vivo removal was completed on (b)(6) 2023.

• Brand Name: PRODISC C VIVO US IMPLANT LARGE-DEEP 5MM
• Common Device Name: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): CENTINEL SPINE; 900 airport road; suite 3b; west chester PA 19380
• Manufacturer (Section G): CENTINEL SPINE; 900 airport road; suite 3b; west chester PA 19380
• Manufacturer Contact: erin ward ; 900 airport road; suite 3b; west chester, PA 19380
• MDR Report Key: 18320261
• Report Number: 3007494564-2023-00078
• Device Sequence Number: 12602158
• Product Code: MJO
• UDI-Device Identifier: 00843193113764
• UDI-Public: 00843193113764
• 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: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/13/2023

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: PDVLD5
• Device Catalogue Number: N/A
• Device Lot Number: 2022-1210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2023
• Initial Report FDA Received Date: 12/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/26/2023
• 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: 52 YR
• Patient Sex: Male