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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG CRANIOFIX 2 TITANIUM CLAMP 11MM CRANIAL CLOSURE

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AESCULAP AG CRANIOFIX 2 TITANIUM CLAMP 11MM CRANIAL CLOSURE Back to Search Results
Model Number FF490T
Device Problem Loose or Intermittent Connection (1371)
Patient Problem Failure of Implant (1924)
Event Date 10/01/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Manufacturing site evaluation: according to the available information, there were no negative consequences for patient. Received the upper disc of an ff490t. At the first sight, there are no damages visible. A visual inspection of the disc, especially the spring segments. The disc is not bent or scratched. Only slight wear marks (caused by the application) are visible. The spring segments are in a proper condition (not bent or damaged). The definitive lot is unknown. The possible lots (52397378 / 52436748), been checked and found to be according to specification valid during the time of production. There are no similar cases at hand since the last three years. The root cause for the problem is most probably usage related. A capa is not necessary.
 
Event Description
It was reported by the healthcare professional to the company sales representative "when procedure of closing the skull, upper disk was loosened after the procedure. When the procedure was complete, the lower disk and pin remained. Feedback of the surgeon; free bone flap was relatively big, but fixed with 3 clamps. The surgeon decided to leave the clamp without upper disk. Currently no detailed information about surgery delay of 15 minutes or more. Information is requested. Only the upper disk is available for the investigation. There are two possible batch numbers reported from by the hospital. One is 52397378 and the other is 52436748. According to the hospital, it is possible that 52436748 is the one used. Received contaminated upper disk.
 
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Brand NameCRANIOFIX 2 TITANIUM CLAMP 11MM
Type of DeviceCRANIAL CLOSURE
Manufacturer (Section D)
AESCULAP AG
po box 40
tuttlingen, 78501
GM 78501
Manufacturer (Section G)
AESCULAP AG
po box 40
tuttlingen, 78501
GM 78501
Manufacturer Contact
nicole broyles
615 lambert pointe drive
hazelwood, MO 63042
3145515988
MDR Report Key8020099
MDR Text Key125506438
Report Number9610612-2018-00479
Device Sequence Number1
Product Code GXN
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K972332
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/30/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFF490T
Device Catalogue NumberFF490T
Device Lot Number52376018
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/17/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date10/10/2018
Event Location No Information
Date Manufacturer Received10/03/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/30/2018 Patient Sequence Number: 1
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