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); Naturally Worn (2988)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

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.Linked to mfg report no.: 3004608878-2019-00216.

Event Description

This is 2 of 2 reports.A sales representative reported in behalf of the customer that the a1059 mayfield modified skull clamp had issues with the swivel lock being loose and also had worn teeth on the starburst.Received additional information from customer on (b)(6) 2019 that the problem was not a patient related incident and it was something that was discovered during the inspection of the unit prior to putting the device into service.Additional information has been requested.

Manufacturer Narrative

The failure analysis could not be completed due to the lack of information received to perform a complete investigation.No material has returned for evaluation.A dhr review could not be performed at this time as the serial number provided (b)(6) does not appear to be a valid integra number.This review will take place once number is verified.The reported complaint was unconfirmed.Root cause analysis cannot be completed at the moment.

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: 8920814
• MDR Text Key: 155208386
• Report Number: 3004608878-2019-00217
• 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: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2019
• 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?: No
• Date Manufacturer Received: 09/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1