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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG 6 CRANIOFIX ABSORBABL.CLAMP STERILE 11MM; CRANIAL FIXATION
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AESCULAP AG 6 CRANIOFIX ABSORBABL.CLAMP STERILE 11MM; CRANIAL FIXATION Back to Search Results
Model Number FF016
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
 
Event Description
It was reported that there was an issue with 6 craniofix absorbable clamp.It was reported that during the operation the line was broken.There was no patient harm.Additional information was not provided nor available / was not available.Additional patient information is not available.The adverse event / malfunction is filed under (b)(4).
 
Manufacturer Narrative
Batch history review: the manufacturing documents have been checked and found to be according to specification valid during the time of production.Conclusion and root cause: the root cause for the problem is most probably usage related.Rationale: we assume, that the surgeon applied abrupt a too high force on the implant during insertion / tightening.A further possible root cause is the usage of some sharp edged instruments during application.A material defect or a manufacturing error can be excluded.
 
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Brand Name
6 CRANIOFIX ABSORBABL.CLAMP STERILE 11MM
Type of Device
CRANIAL FIXATION
Manufacturer (Section D)
AESCULAP AG
po box 40
tuttlingen, 78501
GM  78501
MDR Report Key10116149
MDR Text Key194009012
Report Number9610612-2020-00181
Device Sequence Number1
Product Code GXN
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 07/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/31/2023
Device Model NumberFF016
Device Catalogue NumberFF016
Device Lot Number52449455
Was Device Available for Evaluation? Yes
Date Manufacturer Received07/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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