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

Catalog Number A1059

Device Problems Mechanical Problem (1384); Device Slipped (1584)

Patient Problem Injury (2348)

Event Date 10/27/2019

Event Type  Injury  

Manufacturer Narrative

The device was not yet received by the manufacturer for evaluation.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.Linked to mfg report no.: 3004608878-2019-01099.

Event Description

This is 2 of 2 reports.A sales representative reported on behalf of the customer that the a1059 mayfield modified skull clamp was involved in a case where there was a slip on (b)(6) 2019.The device also had a lighter lock mechanism.There was an unspecified patient injury reported.The surgeon believed that the slippage had nothing to do with the device; that it was due to the patient being elderly with thin skin.Additional information has been requested.

Manufacturer Narrative

Device identifier # (b)(4).The device was returned for evaluation.The device history record (dhr) was reviewed and no anomalies were observed.The device passed all required inspection points with no associated mrr's, variances or rework.With respect to the returned unit it has passed all specific functional testing requirements, when unit is properly positioned and put under pressure unit would not have slipped.Therefore, the reported complaint is not confirmed.The definite root cause of the reported complaint cannot be reliably determined.

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: 9349963
• MDR Text Key: 167968723
• Report Number: 3004608878-2019-01100
• 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: 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: A1059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2019
• Date Manufacturer Received: 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1