MAUDE Adverse Event Report: AESCULAP AG&CO KG CRANIOFIX 2 TITANIUM CLAMP 20MM; CRANIAL CLOSURE

Model Number FF492T

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 04/08/2014

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).Client complained.During a surgery, the surgeon tried to tighten the cranial bone by 4 points, using ff492t.However, 2 of them could not be fixed properly and then the upper disks came off.

Manufacturer Narrative

Us reporting agent notified on: (b)(4) 2014.Mfg site evaluation: 2 of the 4 craniofixes have been cut too short.It can be clearly seen that the pt has been cut off too short where there are no more anti-slip serrations.The cause for the loosening of the plate is that the pt has been cut too short.This failure is user related.The mfg documentation has been checked and found to be according to the specifications valid at the time of production.There are no indications for a material or mfg defect.

• Brand Name: CRANIOFIX 2 TITANIUM CLAMP 20MM
• Type of Device: CRANIAL CLOSURE
• Manufacturer (Section D): AESCULAP AG&CO KG; tuttlingen, de 7853 2
• Manufacturer (Section G): AESCULAP AG&CO KG; tuttlingen 7850 1; GM 78501
• Manufacturer Contact: michelle link ; 615 lambert pointe dr; hazelwood, MO 63042 ; 3145515938
• MDR Report Key: 4047651
• MDR Text Key: 4906588
• Report Number: 2916714-2014-00622
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• PMA/PMN Number: K972332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FF492T
• Device Catalogue Number: FF492T
• Device Lot Number: 51992528
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2013
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other