MAUDE Adverse Event Report: AESCULAP AG AND CO KG CRANIOFIX 2 TITANIUM CLAMP 20MM; NEURAL FIXATION PLATE

Model Number FF492T

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 01/31/2014

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).When surgeon tried to fasten the upper disk by the applier, the pin and the upper disk were coming off even though he never cut th pin.Surgeon has been insisting that he did not cut the pin of craniofix.Operation was delayed over 15 minutes.

Manufacturer Narrative

Us reporting agent notified on: (b)(4) 2014.Manufacturing site evaluation: no other complaints within this batch.Manufacturing records show no deviations form the specifications.The received clamp clearly shows a line caused by a pair of pliers.The statement of the surgeon, he did not cut the pin, is incorrect.There are no hints for product or materials deviations.

• Brand Name: CRANIOFIX 2 TITANIUM CLAMP 20MM
• Type of Device: NEURAL FIXATION PLATE
• Manufacturer (Section D): AESCULAP AG AND CO KG; tuttlingen 7853 2; GM 78532
• Manufacturer (Section G): AESCULAP AG AND CO KG; po box 40; tuttlingen 7850 1; GM 78501
• Manufacturer Contact: michelle link ; 615 lamber pointe drive; hazelwood, MO 63042 ; 3145515938
• MDR Report Key: 3786527
• MDR Text Key: 4363437
• Report Number: 2916714-2014-00202
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K972332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2014
• 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: 51942600
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1