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

Model Number	09.820.026S
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Neck Pain (2433)
Date of Event	11/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that on (b)(6) 2021 a patient was implanted with a prodisc c device at level c5-6.The patient complained of neck pain and right sided radiculopathy pain.It was found that the superior endplate showed subsidence and instability.The pdc device was removed on (b)(6) 2023, patient was revised to a cage and plate system.An mdr was indicated in this complaint.A review of the dhr could not be completed as synthes was the manufacturer of this implant and the dhr cannot be located at this time.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 clinical benefits outweigh the risks.The implant was returned to exponent for third party device evaluation.Exponent will complete the evaluation under report number (b)(4) based upon their approved report protocols.It was confirmed that a removal took place due to subsidence of the superior plate.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
On (b)(6) 2021 a patient was implanted with a prodisc c device at level c5-6.The patient complained of neck pain and right sided radiculopathy pain.It was found that the superior endplate showed subsidence and instability.The pdc device was removed on (b)(6) 2023, patient was revised to a cage and plate system.

• Brand Name: PRODISC C US IMPLANT MEDIUM 6MM
• Common Device Name: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): CENTINEL SPINE; 900 airport road; suite 3b; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: erin ward ; 900 airport road; suite 3b; west chester, PA 19380
• MDR Report Key: 18237495
• Report Number: 3007494564-2023-00069
• Device Sequence Number: 12496679
• Product Code: MJO
• UDI-Device Identifier: 10705034763736
• UDI-Public: 10705034763736
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 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): 11/29/2023

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: 09.820.026S
• Device Catalogue Number: N/A
• Device Lot Number: H580263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2023
• Initial Report FDA Received Date: 11/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 55 YR
• Patient Sex: Female