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 Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A customer reported that the mayfield skull clamp did not lock or is broken.It is unknown if there was patient involvement or if the device failure led to patient injury or surgical delay.

Event Description

N/a.

Manufacturer Narrative

Unique device identifier (udi): (b)(4).Mayfield skull clamp was returned for evaluation.Unit received with the lock having rotational and lateral movement, was hard to lock and had a residue buildup present.Unit needed new components added to replace worn internal parts.The unit was inspected and found to have worn internal parts.The unit had general maintenance and cleaning performed, the worn parts were replaced and the unit was returned, functioning as intended.This unit is beyond integra¿s 7 years recommended life cycle (manufactured in 2010).

• 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: 10802399
• MDR Text Key: 215101276
• Report Number: 3004608878-2020-00663
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 10/08/2020

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: 107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Initial Date Manufacturer Received: 10/08/2020
• Initial Date FDA Received: 11/06/2020
• Supplement Dates Manufacturer Received: 11/06/2020
• Supplement Dates FDA Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1