MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION MAYFIELD MODIFIED SKULL CLAMP; NONE

Catalog Number A1059

Device Problem Insufficient Information (3190)

Patient Problem Laceration(s) (1946)

Event Date 03/11/2015

Event Type  Injury  

Event Description

During a suboccipital craniotomy, when the resident used the "perforator', he said the patient's head moved.The patient was initially in a prone position.The patient was repositioned under the drapes and incurred a laceration which required staples.The procedure was delayed maybe 5 - 10 minutes, wile the resident had to reapply the c clamp., using the same pins.The pin was disposable #a1083 lot.# 1144111.

Manufacturer Narrative

To date, the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based upon the reported information.

• Brand Name: MAYFIELD MODIFIED SKULL CLAMP
• Type of Device: NONE
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; cincinnati OH 45227
• Manufacturer Contact: linda serentino ; 315 enterprise drive; 6099365560
• MDR Report Key: 4671487
• MDR Text Key: 5693253
• Report Number: 3004608878-2015-00115
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A1059
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/12/2015
• Initial Date FDA Received: 04/07/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 72 YR