FDA Adverse Event Injury Summary report: N

BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM

MDR report key: 10448746 · Received August 24, 2020

Report

Report Number: MW5096248
Event Type: Injury
Date Received: August 24, 2020
Date of Event: May 1, 2020
Report Date: December 16, 2020
Manufacturer: EBI, LLC / ZIMMER BIOMET BONE HEALING TECHNOLOGIES
Product Code: LOF
Adverse Event: Yes
Product Problem: Yes
Report Source: Voluntary report
Reporter Location: AZ, US
Reporter Occupation: PATIENT

Narratives

Description of Event or Problem · 1

CALLER CALLED TO REPORT THAT WHEN SHE HAS POSITIONED THE STRAP AROUND HER CALF THE PAIN SHE FELT AWOKE HER FROM HER SLEEP AND SHE COULD NOT WALK DUE TO PAIN BELOW HER KNEE. SHE ALSO, REPORTS THAT THE PATCHES THAT ATTACHED TO THE ELECTRODES DON'T STICK AND SHE HAS RECEIVED REPLACEMENT PATCHES FROM THE PATIENT CARE ADVOCATE (B)(6). REPORTER STATES THAT SHE WAS "ADVISED BY THEM TO REPORT TO THE FDA THE PROBLEMS THAT SHE HAS HAD WITH THIS DEVICE". THE REPORTER ALSO REQUEST THAT IF ANYONE NEEDS TO CALL HER INCLUDING THE MANUFACTURER THAT THEY ONLY CALL HER AFTER 1:00 PM PACIFIC TIME.

Description of Event or Problem · 1

ADD'L INFO RECEIVED FROM REPORTER ON 11/14/2020 FOR MW5096248: AS REQUESTED, THE NIGHT I STRAPPED TRANSMITTER TO JUST ABOVE CALF (TO AVOID SLIDING DOWN), I AWAKENED TO EXCRUCIATING PAIN JUST BELOW KNEE ON SIDE OF LEFT LEG, AND COULDN'T EVEN WALK ON IT THAT DAY SINCE. SAME HAS HAPPENED FOR AN HOUR OR TWO, ABOUT EVERY 10 DAYS OR SO.

Description of Event or Problem · 1

ADDITIONAL INFORMATION RECEIVED FOR REPORT MW5096248 ON 12/16/2020; RE: UPDATE FORM SENT THIS WEEK. RE: DEVICE (ACCESS # MW5096248) AND DRUG ITEM ON AZ BOARD (CASE# (B)(4)).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
910921	BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM	STIMULATOR, BONE GROWTH, NON-INVASIVE	LOF	EBI, LLC / ZIMMER BIOMET BONE HEALING TECHNOLOGIES	1067721	1946

Patients

Seq	Age	Sex	Outcome	Treatment
1	64 YR		Other\| S