FDA Adverse Event Injury Summary report: N

BIOMET ORTHOPAK BONE GROWTH STIMULATOR

MDR report key: 19051658 · Received April 4, 2024

Report

Report Number
MW5153574
Event Type
Injury
Date Received
April 4, 2024
Date of Event
February 9, 2024
Report Date
April 4, 2024
Manufacturer
ZIMMER BIOMET SPINE LLC
Product Code
LOF
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
FL, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

REPORTER CALLING, STATING SHE HAD SPINAL SURGERY IN HER NECK ON (B)(6) 2024, AND WAS DISCHARGED TWO DAYS LATER, ON (B)(6) 2024. REPORTER STATES THAT UPON DISCHARGE SHE WAS INSTRUCTED TO USE A BIOMET ORTHOPAK BONE GROWTH STIMULATOR FOR SIX MONTHS. REPORTER STATES SHE WEARS THE DEVICE EVERY DAY, AS INSTRUCTED, BUT HAS BEEN HAVING PROBLEMS. REPORTER STATES THE INCLUDED ELECTRODES CAUSE HER SKIN TO ITCH AND THEY ARE "TOO ADHESIVE" AND CAUSE CONSTANT SKIN IRRITATION. REPORTER STATES THERE WAS ALSO A PROBLEM WITH THE BATTERY THAT WAS ONLY RECENTLY DISCOVERED. REPORTER STATES AS A RESULT SHE HAS BEEN WEARING THE DEVICE FOR TWO MONTHS HOWEVER RECENTLY LEARNED THAT THE DEVICE WASN'T WORKING DURING THIS TIME. REPORTER STATES SHE HAS CONCERNS ABOUT HER HEALING AND RECOVERY PROCESS AFTER HER SPINAL NECK SURGERY, AND FEARS THAT LACK OF TREATMENT THESE PAST TWO MONTHS HAS PUT HER RECOVERY BEHIND. REPORTER STATES A NEW DEVICE IS BEING SENT TO HER BUT IT HAS NOT YET ARRIVED. ADDITIONALLY, REPORTER STATES SHE WILL BE FOLLOWING UP WITH HER SURGEON'S OFFICE REGARDING HER CONCERNS ABOUT RECOVERY AND THE HEALING PROCESS. REPORTER STATES SHE FEELS THIS DEVICE HAS BEEN DETRIMENTAL TO HER HEALTH.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
104411 BIOMET ORTHOPAK BONE GROWTH STIMULATOR STIMULATOR, BONE GROWTH, NON-INVASIVE LOF ZIMMER BIOMET SPINE LLC

Patients

Seq Age Sex Outcome Treatment
1 81 YR Female Other