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

Model Number FF492T

Device Problem Product Quality Problem (1506)

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

Event Date 03/19/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that there was an issue with ff492t - craniofix 2 titanium clamp 20mm.According to the complaint description, the discs of the top could not be held and came loose when the surgeon tried to close the skull with the products.An additional medical intervention was necessary.Additional information was not available.Additional patient information is not available.The adverse event / malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Updated b1 + b2: adverse event.Updated b5: patient harm.Updated h6: codes.Investigation results: visual investigation: the implant arrived in decontaminated condition.The pin of the lower disc is cut off skewed and strongly bent, the upper disc exhibit no defects at the first sight.We made a visual inspection of the lower disc and its pin.The disc is strongly bent and the pin is cut off skewed.The last fixation rim underneath the skewed cut off pin is strongly damaged.In the next step we investigated the upper disc.Here we found one of the spring segments strongly bent upward.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity 2(5) x probability of occurrence 2(5)) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigations results a capa is not necessary.

Event Description

Additional information: patient harm changed to additional medical intervention 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: 11674838
• MDR Text Key: 266745625
• Report Number: 9610612-2021-00307
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FF492T
• Device Catalogue Number: FF492T
• Device Lot Number: 52575601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2021
• Date Manufacturer Received: 08/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention