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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD MODIFIED SKULL CLAMP; SKULL CLAMPS AND HEADREST SYSTEMS
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INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD MODIFIED SKULL CLAMP; SKULL CLAMPS AND HEADREST SYSTEMS Back to Search Results
Catalog Number A1059
Device Problem Mechanical Jam (2983)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
A customer reported that the lock of the a1059 mayfield modified skull clamp was hard to turn.There was no known surgery delay or patient injury.
 
Manufacturer Narrative
Unique device identifier (udi): (b)(4).The mayfield skull clamp was returned for evaluation: device history record (dhr) - no abnormalities related to the reported failure shown in dhrs found for lot# 124.Complaint confirmed via inspection of the unit.Unit received with the lock having rotational and lateral movement and was difficult to lock due to wear.Unit needed new components added to replace worn internal parts.With respect to the complaint, it was confirmed the returned unit did not meet all specific functional tests.
 
Event Description
N/a.
 
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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 Key10659112
MDR Text Key211103328
Report Number3004608878-2020-00593
Device Sequence Number1
Product Code HBL
Combination Product (y/n)N
PMA/PMN Number
PRE-AMEND
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 09/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberA1059
Device Lot Number124
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/29/2020
Date Manufacturer Received10/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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