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

Model Number UNKNOWN

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Dysphagia/ Odynophagia (1815)

Event Date 09/26/2023

Event Type  Injury  

Manufacturer Narrative

It was reported that a patient was implanted with a prodisc c implant in (b)(6) 2023.Following surgery the patient had difficulty swallowing and pain in their arm.It was found that the device had retropulsed out of the disc space.The removal was completed on (b)(6) 2023, the patient was converted to a fusion using a stalif c implant.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 cannot be completed as the patient requested to keep the implant following removal.It was confirmed that a removal took place due to implant retropulsion / posterior migration.No other anomalies associated with the complaint were found during the investigation.This submission is 1 of 1 devices involved in this event.

Event Description

Patient was implanted with a prodisc c implant in (b)(6) 2023.Following surgery the patient had difficulty swallowing and pain in their arm.It was found that the device had retropulsed out of the disc space.The removal was completed on (b)(6) 2023, the patient was converted to a fusion using a stalif c implant.

• Brand Name: PRODISC C US IMPLANT
• Type of Device: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): CENTINEL SPINE; 900 airport road; suite 3b; west chester PA 19380
• Manufacturer (Section G): FRÜH 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: 17888806
• MDR Text Key: 325134488
• Report Number: 3007494564-2023-00053
• 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: 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2023
• 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?: No
• Date Manufacturer Received: 09/18/2023
• 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: 33 YR
• Patient Sex: Female