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

Model Number 09.820.035S

Device Problems Use of Device Problem (1670); Positioning Problem (3009)

Patient Problem Intervertebral Disc Compression or Protrusion (4524)

Event Date 04/13/2022

Event Type  Injury  

Event Description

Patient was implanted with two prodisc c implants at level c 4/5 and c 5/6 by implanting surgeon on (b)(6) 2018.It was found that the implants were positioned poorly and that the posterior portion of the implants were in the spinal canal.The patient had also auto-fused.The removing surgeon, stated that there was no indication of a problem or a malfunction with the device itself, but rather that poor placement of the devices was a contributing factor.Patient was revised on (b)(6) 2022 and the pdcs were replaced with fusion interbody cages.

Manufacturer Narrative

The information provided indicates that the patient received a 2-level prodisc c implantation.At nearly 4 years post-op, the patient was scheduled for removal of both devices.The implants were positioned poorly and the posterior portion of the implants was in the spinal canal, the patient had also auto-fused.The removal was performed on (b)(6) 2022, and the pdc devices were replaced with fusion interbody cages.Synthes was the manufacturer of the implants, and the dhr has been requested from them to be reviewed.Complaint rates were found to be acceptable based on the analysis of the updated dfmea rates.The risk assessment determined the dmfea has identified the risks associated with this complaint.The devices were retained by the patient and no device evaluation could be completed.The investigation concluded that the positioning of the devices is likely the cause of the complaint and removal.This positioning is attributed to use error while implanting the device.This submission is 1 of 2 for this event.

• Brand Name: PRODISC C US IMPLANT MEDIUM-DEEP 5MM
• 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
• MDR Report Key: 14318174
• MDR Text Key: 293162142
• Report Number: 3007494564-2022-00031
• 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: 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 09.820.035S
• Device Lot Number: 9947541
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 39 YR
• Patient Sex: Female