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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 01/06/2017
Event Type  malfunction  
Manufacturer Narrative
Investigation: used test and analysis equipment; keyence-vhx 600 d microscope; (b)(4) digital camera. We made a visual inspection of the pin in the lower disc. Here we found a slightly skewed cutting edge with a damaged uppermost fixation rim. Next we investigated the upper disc. The disc is completely bent from inside to the outside. 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 pin was skew cut. One of the spring segments couldn't get fixed, the disc seems loose. The surgeon tried to take down the disc, causing the disc to bend (the other spring segments stuck at the fixation rim). The ifu contains clear guidelines for inserting the implant and cutting the pin. The risk of coming off the pin during incorrect 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 when using the pin cutter upper disk was loose.
 
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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 Key6387169
MDR Text Key197011140
Report Number9610612-2017-00132
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
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 Received03/08/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2021
Device Model NumberFF492T
Device Catalogue NumberFF492T
Device Lot Number52268829
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/07/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date02/28/2017
Device Age5 MO
Event Location No Information
Date Manufacturer Received01/18/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/30/2016
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: 03/08/2017 Patient Sequence Number: 1
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