FDA Adverse Event Injury Summary report: N

JAZZ

MDR report key: 9852259 · Received March 19, 2020

Report

Report Number
3007675554-2020-00001
Event Type
Injury
Date Received
March 19, 2020
Date of Event
February 11, 2020
Report Date
March 12, 2020
Manufacturer
IMPLANET
Product Code
OWI
PMA / PMN Number
K170730
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
FR
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL

Narratives

Description of Event or Problem · 1

FOR UNKNOWN REASON A PATIENT WAS REVISED ON (B)(6) 2020. DURING THIS NEW SURGERY, THE PHYSICIAN TOOK OUT A JAZZ BAND BECAUSE IT WAS BROKEN. INITIAL SURGERY WAS ON (B)(6) 2018.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
319892 JAZZ JAZZ BAND OWI IMPLANET 150156

Patients

Seq Age Sex Outcome Treatment
1 Required Intervention