MAUDE Adverse Event Report: ZIMMER BIOMET LORENZ OSTEOTOME

Device Problem Dull, Blunt (2407)

Patient Problem Bone Fracture(s) (1870)

Event Date 12/07/2020

Event Type  No Answer Provided  

Event Description

Pt with mandibular condylar hairline fracture due to use of dull osteotome.

• Brand Name: LORENZ OSTEOTOME
• Type of Device: LORENZ OSTEOTOME
• Manufacturer (Section D): ZIMMER BIOMET; 345 e. main st. ; warsaw IN 46580
• MDR Report Key: 12016621
• MDR Text Key: 257479866
• Report Number: MW5101944
• Device Sequence Number: 1
• Product Code: HWM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 23 YR
• Patient Weight: 57