MAUDE Adverse Event Report: AESCULAP AG CRANIOFIX 2 TITANIUM CLAMP 20MM; CRANIAL IMPLANTS

Model Number FF492T

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/17/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.Pending further information.

Event Description

It was reported by the healthcare professional to the company sales representative "during procedure, the upper disk was not able to be fixed, therefore, the disk was loosed.".

Manufacturer Narrative

Investigation: used test and analysis equipment: keyence vhx 5000 digital microscope.Pansonic dmc tz8 digital camera.We made a visual inspection of the single parts.First we investigated the upper disc.We found it warped and bent, the spring segments are bent unequally.In the next step we investigated the pin.We found it cut skewed and bent at several points.At last we investigated the torn off lower pin and the lower disc.The lower disc is also bent and the pin hole exhibits bending and burrs in consequence of pulling out the pin.Batch history review: the manufacturing documents have been checked and found to be according to specification valid during the time of production.There are no further complaints with this batch and error pattern at hand.Conclusion and root cause: the root cause of the problem is most probably usage related.Rationale: without further knowledge about the circumstances we assume, that the surgeon applied too high mechanical force during the application process.Furthermore it is possible, that the implant was incorrectly positioned.A material failure or a manufacturing error can be excluded.No capa is necessary.

• Brand Name: CRANIOFIX 2 TITANIUM CLAMP 20MM
• Type of Device: CRANIAL IMPLANTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 7795237
• MDR Text Key: 117564417
• Report Number: 9610612-2018-00348
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• PMA/PMN Number: K040864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 09/20/2018

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: 02/28/2023
• Device Model Number: FF492T
• Device Catalogue Number: FF492T
• Device Lot Number: 52414077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2018
• Distributor Facility Aware Date: 07/25/2018
• Device Age: 5 MO
• Initial Date Manufacturer Received: 07/20/2018
• Initial Date FDA Received: 08/17/2018
• Supplement Dates Manufacturer Received: 09/12/2018
• Supplement Dates FDA Received: 09/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention