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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD COMPOSITE SERIES SKULL CLAMP; ¿COMPOSITE SERIES¿
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INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD COMPOSITE SERIES SKULL CLAMP; ¿COMPOSITE SERIES¿ Back to Search Results
Catalog Number A3059
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Known Impact Or Consequence To Patient (2692)
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 the mayfield composite series skull clamp (a3059) was too loose.It is unknown if there was patient involvement or if the device failure led to patient injury or surgical delay.
 
Manufacturer Narrative
Mayfield skull clamp (a3059) was not returned for evaluation; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
 
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Brand Name
MAYFIELD COMPOSITE SERIES SKULL CLAMP
Type of Device
¿COMPOSITE SERIES¿
Manufacturer (Section D)
INTEGRA LIFESCIENCES CORPORATION OH/USA
4900 charlemar drive
4900 charlemar drive
cincinnati OH 45227
MDR Report Key11102018
MDR Text Key226095020
Report Number3004608878-2020-00777
Device Sequence Number1
Product Code HBL
Combination Product (y/n)N
PMA/PMN Number
K142238
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 03/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberA3059
Was Device Available for Evaluation? No
Date Manufacturer Received02/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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