MAUDE Adverse Event Report: AESCULAP AG CRANIOPLATE 1.5 SCR.MAG.CROSS L:4MM; CRANIAL FIXATION

Model Number FM921T

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 12/15/2021

Event Type  malfunction  

Event Description

It was reported that there was an issue with fm921t - cranioplate 1.5 scr.Mag.Cross l:4mm.According to the complaint description, the tip was broken.There was no described patient harm.Additional patient information is not available.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation: up to now, products not provided.Therefore, an investigation is not possible.Batch history review: the device quality and manufacturing history records (dhr) have been checked for all leading device(s) lot numbers and the products found to be according to our specification valid at the time of production.There are two similar complaints against the same lot number(s).Explanation and rationale: without the product, an exact cause cannot be determined at this moment.Due to the constant monitoring of the compliance with our quality standards, as matters stand, a production or material defect can most likely be excluded.Conclusion and root cause: due to the current deviation, and according to explanation above, the exact cause cannot be determined.A capa is not necessary.

Manufacturer Narrative

Investigation: up to now, products not provided.Therefore, an investigation is not possible.Batch history review: the device quality and manufacturing history records (dhr) have been checked for all leading device(s) lot numbers and the products found to be according to our specification valid at the time of production.There are two similar complaints against the same lot number(s).Explanation and rationale: without the product, an exact cause cannot be determined at this moment.Due to the constant monitoring of the compliance with our quality standards, as matters stand, a production or material defect can most likely be excluded.Conclusion and root cause: due to the current deviation, and according to explanation above, the exact cause cannot be determined.A capa is not necessary.

Event Description

It was reported that there was an issue with fm921t - cranioplate 1.5 scr.Mag.Cross l:4mm.According to the complaint description, the tip was broken.There was no described patient harm.Additional patient information is not available.The malfunction is filed under aag reference (b)(4).

• Brand Name: CRANIOPLATE 1.5 SCR.MAG.CROSS L:4MM
• Type of Device: CRANIAL FIXATION
• 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: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 13580500
• MDR Text Key: 286020271
• Report Number: 9610612-2022-00062
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K060492
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FM921T
• Device Catalogue Number: FM921T
• Device Lot Number: 52694252
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2021
• 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