MAUDE Adverse Event Report: INTEGRA LIFESCIENCES PRODUCTION CORP. CODMAN DISPOSABLE PERFORATORS; DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)

Patient Problem Insufficient Information (4580)

Event Type  Other  

Event Description

It was reported that perforator broke while the disposable perforator is connected and in use.No patient impact was reported.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: CODMAN DISPOSABLE PERFORATORS
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)
• Manufacturer (Section D): INTEGRA LIFESCIENCES PRODUCTION CORP.
• MDR Report Key: 18212079
• MDR Text Key: 329255449
• Report Number: MW5148523
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 11/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1