MAUDE Adverse Event Report: AESCULAP AG CRANIOFIX 2 TITANIUM CLAMP 11MM; CRANIAL IMPLANTS

Model Number FF490T

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 01/25/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.Device not returned.

Event Description

Country of complaint: usa.It was reported that the patient had craniotomy on (b)(6) 2016 with dural implanted.(left fronto-centro-parietal craniotomy excision of meningioma, implanted dural graft and fixation clips.) it became life threatening, hospitalization and required intervention.On (b)(6) 2017 returned to operating room for intracranial infection.Operation (procedure): left craniectomy, debridement of subdural empyema.Findings: purulent material in the subdural space.Bone flap, fixation clips and dural graft removed.All med watch submissions related to this report are: 9610612-2017-00175, 9610612-2017-00176.

Manufacturer Narrative

Investigation: no product at hand batch history review: the manufacturing documents of both lots have been checked and found to be according to specification valid during the time of production.Conclusions and root cause: the root cause is most probably user related.Rational: the described problem, caused by craniofix ff490t is not known at aag.The sterilization process of the craniofix clamps is tested and validated.Without further knowledge about the circumstances we assume, that the problem was caused by the used foreign article or other unknown circumstances at the hospital.No capa is necessary.

Manufacturer Narrative

Associated medwatch: 9610612-2017-00176.Please note: a retrospective review of potential serious injury complaints was performed.This mdr was identified and filed as part of the review activities.

• Brand Name: CRANIOFIX 2 TITANIUM CLAMP 11MM
• Type of Device: CRANIAL 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: lindsay chromiak ; 3773 corporate parkway; center valley, pa, MO 63042 ; 3145515988
• MDR Report Key: 6520774
• MDR Text Key: 73664857
• Report Number: 9610612-2017-00175
• 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: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: FF490T
• Device Catalogue Number: FF490T
• Device Lot Number: 52246501
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/15/2017
• Device Age: 10 MO
• Initial Date Manufacturer Received: 03/13/2017
• Initial Date FDA Received: 04/25/2017
• Supplement Dates Manufacturer Received: 03/13/2017; 03/13/2017
• Supplement Dates FDA Received: 07/11/2017; 04/01/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2016
• 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
• Patient Outcome(s): Life Threatening; Other; Required Intervention