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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 Problems Loose or Intermittent Connection (1371); Mechanical Problem (1384)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
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
This is 1 of 4 reports linked to mfg report numbers: 3004608878-2021-00244, 3004608878-2021-00245, 3004608878-2021-00246.A facility reported that the mayfield composite series skull clamp (a3059) does not lock correctly and was too loose.It is unknown if there was patient involvement; however, no patient injury or surgical delay has been reported.
 
Manufacturer Narrative
Device history record: the dhr shows no abnormalities related to the reported failure.Mayfield skull clamp (a3059) was returned for evaluation.The reported complaint was confirmed.Evaluation showed that the lock has up and down movement and the teeth are grinding when rotated.The unit needs repair, and replacement of worn parts.General maintenance and cleaning required.
 
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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
MDR Report Key11636327
MDR Text Key244631138
Report Number3004608878-2021-00243
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 04/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2021
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? Device Returned to Manufacturer
Date Returned to Manufacturer03/29/2021
Date Manufacturer Received04/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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