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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG CRANIOFIX 2 TITANIUM CLAMP 16MM CRANIAL IMPLANTS

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AESCULAP AG CRANIOFIX 2 TITANIUM CLAMP 16MM CRANIAL IMPLANTS Back to Search Results
Model Number FF491T
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/18/2017
Event Type  malfunction  
Manufacturer Narrative
Investigation: used test and analysis equipment; -keyence-vhx 600 d; -panasonic dmc tz8 digital camera. We made a visual inspection of the cutting edge of the pin. It was clear to see, that the pin was not cut correctly. The pin cut skewed and through the fixation rim, so a fixation of the upper disc was not possible. 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 of the problem is most probably user related. Rational: the ifu contains clear guidlines for inserting the implant and cutting the pin. The risk of coming off the pin during wrong handling is mentioned. No capa is necessary.
 
Manufacturer Narrative
(b)(4). Manufacturing site evaluation: evaluation on-going.
 
Event Description
Country of complaint: (b)(6). It was reported that the upper disk was still loose after fixing and cutting the pin. There was a 15 minute delay in surgery.
 
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Brand NameCRANIOFIX 2 TITANIUM CLAMP 16MM
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 Key6640232
MDR Text Key197021611
Report Number9610612-2017-00320
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 company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2021
Device Model NumberFF491T
Device Catalogue NumberFF491T
Device Lot Number52269871
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/07/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date06/02/2017
Device Age9 MO
Event Location No Information
Date Manufacturer Received05/23/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/15/2016
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: 06/14/2017 Patient Sequence Number: 1
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