FDA Adverse Event Injury Summary report: N

PRODISC C US IMPLANT

MDR report key: 11957292 · Received June 8, 2021

Report

Report Number: 3007494564-2021-00049
Event Type: Injury
Date Received: June 8, 2021
Date of Event: May 17, 2021
Report Date: June 7, 2021
Manufacturer: CENTINEL SPINE, LLC.
Product Code: MJO
PMA / PMN Number: P070001
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 1

THE INFORMATION PROVIDED INDICATES THE PATIENT UNDERWENT PDC REMOVAL DUE TO CONTINUED PAIN AND RADICULAR SYMPTOMS. THERE WAS NO INDICATION OF A DEVICE PROBLEM OR MALFUNCTION. THIS INFORMATION AS WELL AS PREVIOUS COMPLAINTS OF THIS TYPE LED TO A DETERMINATION THAT AN MDR SUBMISSION IS REQUIRED. DHR REVIEW COULD NOT BE COMPLETED AS PART AND LOT NUMBERS WERE NOT PROVIDED. COMPLAINT TRENDING FOUND THE RATE OF COMPLAINTS FOR THIS TYPE TO BE REMOTE PROBABILITY FOR REMOVAL AND PAIN. THE RISK ASSESSMENT FOUND THE RISKS OF THIS COMPLAINT ARE IDENTIFIED PER THE PDC DFMEA. NO DEVICE WAS RETRIEVED FOR EVALUATION. THE INVESTIGATION FOUND NO DEVICE RELATED PROBLEM OR CAUSE FOR THIS COMPLAINT. THIS SUBMISSION IS FOR 1 OF 1 DEVICES INVOLVED IN THIS EVENT.

Description of Event or Problem · 1

A PRODISC C REMOVAL WAS PERFORMED ON 5/17/2021 DUE TO PERSISTENT NECK PAIN AND RADICULAR SYMPTOMS. THE DEVICE WAS IMPLANTED ON AN UNKNOWN DATE BY AN UNKNOWN SURGEON. THE PRODISC C WAS REPORTED IN GOOD CONDITION AND FUNCTIONING NORMALLY. THE CLINICAL IMPRESSION LED TO THE SURGEON'S DECISION TO REPLACE THE PRODISC C DEVICE WITH A FUSION USING AN UNKNOWN DEVICE. THE REMOVAL AND REPLACEMENT WAS COMPLETED WITHOUT ISSUE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
855883	PRODISC C US IMPLANT	PROSTHESIS, INTERVERTEBRAL DISC	MJO	CENTINEL SPINE, LLC.	UNKNOWN	UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention