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

Catalog Number A1059

Device Problem Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/19/2019

Event Type  malfunction  

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.: 3004608878-2019-00984 and 3004608878-2019-00987.

Event Description

This is 3 of 3 reports.A sales representative reported in behalf of the customer that the a1059 mayfield modified skull clamp slipped.Additional information received on 03sep2019 indicating that the event happened during a craniotomy procedure on (b)(6) 2019.No adverse event reported.

Event Description

N/a.

Manufacturer Narrative

Device identifier 10381780253457.The device was returned for evaluation.No issues observed from the evaluation.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.Pm maintenance and cleaning required at this time.The device exceeded it's expected life of seven (7) years.The reported complaint is not confirmed.The definite root cause of the reported condition cannot be reliably determined.

• 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: 9075925
• MDR Text Key: 189765868
• Report Number: 3004608878-2019-00990
• 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: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2019
• 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: 014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2019
• Date Manufacturer Received: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1