STERNALOCK 360 MULTI-IMPLANT SYSTEM N/A 74-0004

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-31 for STERNALOCK 360 MULTI-IMPLANT SYSTEM N/A 74-0004 manufactured by Biomet Microfixation.

MAUDE Entry Details

• Report Number: 0001032347-2020-00188
• MDR Report Key: 9905485
• Report Source: HEALTH PROFESSIONAL,USER FACI
• Date Received: 2020-03-31
• Date of Report: 2020-03-31
• Date of Event: 2020-03-13
• Date Mfgr Received: 2020-03-13
• Device Manufacturer Date: 2018-08-14
• Date Added to Maude: 2020-03-31
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MRS. JENNIFER DELANEY
• Manufacturer Street: 1520 TRADEPORT DRIVE
• Manufacturer City: JACKSONVILLE FL 32218
• Manufacturer Country: US
• Manufacturer Postal: 32218
• Manufacturer Phone: 9047414400
• Manufacturer G1: BIOMET MICROFIXATION
• Manufacturer Street: 1520 TRADEPORT DRIVE
• Manufacturer City: JACKSONVILLE FL 32218
• Manufacturer Country: US
• Manufacturer Postal Code: 32218
• Single Use: 3
• Previous Use Code: 3
• Removal Correction Number: N/A
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: STERNALOCK 360 MULTI-IMPLANT SYSTEM
• Generic Name: PLATE, FIXATION, BONE
• Product Code: HRS
• Date Received: 2020-03-31
• Model Number: N/A
• Catalog Number: 74-0004
• Lot Number: 253130
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BIOMET MICROFIXATION
• Manufacturer Address: 1520 TRADEPORT DRIVE JACKSONVILLE FL 32218 US 32218

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-03-31