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

Model Number UNKNOWN

Device Problem Off-Label Use (1494)

Patient Problem Insufficient Information (4580)

Event Date 09/12/2023

Event Type  Injury  

Event Description

It was reported that a patient was implanted with a prodisc c in 2014.The patient had no issues with the pdc device until a two level acdf was implanted below the pdc construct.Patient became symptomatic and the pdc was removed on (b)(6) 2023 and replaced with a cervical plate and spacer.

Manufacturer Narrative

It was reported that a patient was implanted with a prodisc c in 2014.The patient had no issues with the pdc device until a two level acdf was implanted below the pdc construct.Patient became symptomatic and the pdc was removed on (b)(6) 2023 and replaced with a cervical plate and spacer.A dhr review could not be completed because the lot number and part number could not be determined through the investigation.Complaint trending found that the rate of complaints was found to be at a level where the clinical benefits outweigh the risks.A review of the risk assessment found that the risks associated with the complaint are identified and mitigated to an acceptable level.The implant was returned and will be evaluated by exponent following their validated prodisc c device evaluation protocol under pdc-rd-0052.There were no anomalies identified during the complaint investigation.Patient's symptoms developed after the placement of a fusion device below the prodisc c implant, it can be determined that the off label use lead to the removal surgery.This submission is 1 of 1 devices involved in this event.

• Brand Name: PRODISC C US IMPLANT
• Type of Device: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): CENTINEL SPINE, LLC; 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 ; 4848878894
• MDR Report Key: 17813221
• MDR Text Key: 324191845
• Report Number: 3007494564-2023-00048
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2023
• Date Manufacturer Received: 09/06/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR