MAUDE Adverse Event Report: AESCULAP AG CRANIOFIX 2 TITANIUM CLAMP 11MM; PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE

Model Number FF490T

Device Problem Incomplete or Missing Packaging (2312)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/29/2020

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported to aesculap ag that a craniofix 2 titanium clamp 11mm (part # ff490t) was to be used during a neurosurgery procedure performed on (b)(6) 2020.According to the complainant, the blister pack from the second package was incomplete.The procedure was able to be successfully completed using a replacement device.No patient complications occurred as a result of this event.Additional information has been requested, but has not been made available.The malfunction is filed under aag reference cc (b)(4).

Manufacturer Narrative

Based upon new information received, this event was re-evaluated and is considered no longer reportable - no malfunction or serious injury.Since the risk analysis was outdated a retrospective review from 25.07.2018 until 21.12.2020 was performed with the results that no patient harm had been reported due to this hazard; the defined severity was still adequate.

• Brand Name: CRANIOFIX 2 TITANIUM CLAMP 11MM
• Type of Device: PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10836494
• MDR Text Key: 249643551
• Report Number: 9610612-2020-00848
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 04038653379569
• UDI-Public: 4038653379569
• Combination Product (y/n): N
• PMA/PMN Number: K122353
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FF490T
• Device Catalogue Number: FF490T
• Device Lot Number: 52622723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2020
• Date Manufacturer Received: 12/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1