• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

AESCULAP AG CRANIOFIX 2 TITANIUM CLAMP 16MM CRANIAL IMPLANTS Back to Search Results
Model Number FF103R
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/07/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Manufacturing site evaluation: according to the available information there were no negative consequences for the patient. The pin cutter shows no outwardly defects. The clamp arrived in three parts, pin, upper disc and lower disc. Used test -and analysis: microscope, digital camera. A visual inspection of the lower disc, especially the pin and its cutting edge. The lower disc exhibits a pin which was cut skewed and underneath the last rims, so the disc must came off. Furthermore performed some cutting tests with the pin cutter. The pin cutter worked properly without any problems. The detached implant and the pin - cutter in their incoming condition. The manufacturing documents have checked and found to be according to specification valid during the time of production. The root cause for the problem is most probably usage related. The pin of the clamp was cut underneath the last fixation rim. A capa is not necessary.
 
Event Description
Country of complaint: (b)(6). It was reported that after cutting pin, upper disk was loosened. No injury for patient was reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
MDR Report Key7562291
MDR Text Key109888456
Report Number9610612-2018-00228
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
Report Date 06/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/01/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/01/2012
Device Model NumberFF103R
Device Catalogue NumberFF103R
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/23/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Distributor Facility Aware Date05/25/2018
Device Age5 YR
Event Location No Information
Date Manufacturer Received05/07/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2012
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: 06/01/2018 Patient Sequence Number: 1
-
-