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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG CRANIOFIX 2 TITANIUM CLAMP 20MM CRANIAL IMPLANTS

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AESCULAP AG CRANIOFIX 2 TITANIUM CLAMP 20MM CRANIAL IMPLANTS Back to Search Results
Model Number FF492T
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/17/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Manufacturing site evaluation: evaluation on-going. Pending further information.
 
Event Description
It was reported by the healthcare professional to the company sales representative "during procedure, the upper disk was not able to be fixed, therefore, the disk was loosed. ".
 
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Brand NameCRANIOFIX 2 TITANIUM CLAMP 20MM
Type of DeviceCRANIAL IMPLANTS
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 Key7795237
MDR Text Key117564417
Report Number9610612-2018-00348
Device Sequence Number1
Product Code GXN
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K040864
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,Followup
Report Date 09/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFF492T
Device Catalogue NumberFF492T
Device Lot Number52414077
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/31/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date07/25/2018
Device Age5 MO
Event Location No Information
Date Manufacturer Received09/12/2018
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: 08/17/2018 Patient Sequence Number: 1
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