MAUDE Adverse Event Report: CENTINEL SPINE, LLC. PRODISC C TOTAL DISC REPLACEMENT; PROSTHESIS, INTERVERTEBRAL DISC

Model Number UNKNOWN

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Neck Pain (2433)

Event Date 06/18/2020

Event Type  Injury  

Manufacturer Narrative

The patient had the unknown prodisc c device removed due to continued pain.According to the revising surgeon, the implant height was too tall for this patient and placed slightly off midline.The exact date of implantation is not known.The part and lot numbers for the prodisc c device are not known and were not provided.The device was not made available for retrieval by the hospital.Dhr review could not be completed.Rate of complaints was found to be as expected based on the risk assessment.The risk assessment found that the risks associated with this event were identified with no new or previously unknown risks occurring.

Event Description

A patient required a prodisc c removal procedure due to continued pain.Per the revising surgeon, the implant height was too tall for this patient.The revising surgeon also noted the implant appeared to be slightly off midline in the a/p view.

• Brand Name: PRODISC C TOTAL DISC REPLACEMENT
• Type of Device: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): CENTINEL SPINE, LLC.; 900 airport rd, suite 3b; west chester, pa
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester, pa
• Manufacturer Contact: jason smith ; 900 airport rd, suite 3b; west chester, pa ; 8878839
• MDR Report Key: 10279678
• MDR Text Key: 199062749
• Report Number: 3007494564-2020-00026
• 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: 07/15/2020

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
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/17/2020
• Initial Date FDA Received: 07/15/2020
• 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: 48 YR