MAUDE Adverse Event Report: INTEGRA LIFESCIENCES PRODUCTION CORPORATION CODMAN PERFORATOR; DRILLS, BURRS, TREPHINES AND ACCESSORIES (COMPOUND, POWERED)

Device Problem Device Remains Activated (1525)

Patient Problem Unspecified Tissue Injury (4559)

Event Type  Injury  

Event Description

It was reported that during craniotomy procedure, single used codman perforator did not stop and injured the dura.There was a procedure delay of 15 minutes as a result of this event and procedure was completed with backup product.(b)(4) this report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: CODMAN PERFORATOR
• Type of Device: DRILLS, BURRS, TREPHINES AND ACCESSORIES (COMPOUND, POWERED)
• Manufacturer (Section D): INTEGRA LIFESCIENCES PRODUCTION CORPORATION
• MDR Report Key: 17527727
• MDR Text Key: 321057252
• Report Number: MW5134659
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1