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 Consequences Or Impact To Patient (2199)

Event Date 11/13/2020

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 facility reported that during use of the mayfield skull clamp (product id: a1059), the rotational lock on the clamp itself did not hold and then the clamp slipped around the patient¿s head and contacted her nose.There was no harm to the patient because this incident occurred while they were positioning the clamp and they corrected it.The patient was undergoing posterior cervical spine wound irrigation and debridement of surgical site with application of vacuum assisted closure device.There was no adverse impact to the patient besides delay of the procedure, but the time of delay is unknown.

Manufacturer Narrative

Unique device identifier (udi): (b)(4).Device history record (dhr): the dhr shows no abnormalities related to the reported failure.The reported complaint was not confirmed from the evaluation of the returned a1059 mayfield skull clamp.No issues observed from the functional testing of the device.The device was functioning properly.When unit is properly positioned and put under pressure unit would not have slipped.

• 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: 11015322
• MDR Text Key: 221827592
• Report Number: 3004608878-2020-00735
• 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,health
• Type of Report: Initial,Followup
• Report Date: 11/17/2020

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Initial Date Manufacturer Received: 11/17/2020
• Initial Date FDA Received: 12/15/2020
• Supplement Dates Manufacturer Received: 01/06/2021
• Supplement Dates FDA Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1