MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD MODIFIED SKULL CLAMP; SKULL CLAMPS AND HEADREST SYSTEMS

Catalog Number A1059

Device Problem Mechanical Problem (1384)

Patient Problems No Consequences Or Impact To Patient (2199); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

The device was not yet returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A sales representative reported on behalf of the customer that the a1059 mayfield modified skull clamp would not lock when under sixty (60) pounds (lbs.) of pressure.Additional information received on 06feb2019 indicating that the product problem occurred during a craniotomy procedure for the tumor.There was no surgery delay reported.The surgeon used a different skull clamp and the procedure progressed as intended.No patient injury or consequences were noted.

Manufacturer Narrative

Additional information was received on (b)(6) 2019 indicating that the patient was re-pinned when another clamp was used.The device was returned for evaluation and when tested under pressure, the unit locks at all pressure settings.The unit does need some general maintenance.The swivel base has both rotational and lateral movement while in the locked position; this is a result of normal wear and tear.The device history record review showed that the device exceeds its expected life; unit was manufactured in 2009.The complaint was not confirmed.Device identifier (b)(4).

Event Description

N/a.

• Brand Name: MAYFIELD MODIFIED SKULL CLAMP
• Type of Device: SKULL CLAMPS AND HEADREST SYSTEMS
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• MDR Report Key: 8356155
• MDR Text Key: 136863304
• Report Number: 3004608878-2019-00038
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: PRE-AMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A1059
• Device Lot Number: 094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2019
• Initial Date Manufacturer Received: 01/31/2019
• Initial Date FDA Received: 02/20/2019
• Supplement Dates Manufacturer Received: 02/25/2019
• Supplement Dates FDA Received: 03/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SKULL PINS