MAUDE Adverse Event Report: SIGNUS MEDIZINTECHNIK GMBH DIPLOMAT PEDICLE SCREW

Model Number AB0321-75040

Device Problems Fracture (1260); Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Date 04/24/2023

Event Type  malfunction  

Event Description

Pedicle screw broken, this was removed during revision surgery.This incident was reported by the safety officer of the clinic without further information.It was very difficult to obtain informations about the event, as well as the patient's consent form for examination of the explant - screw head with upper part of the pedicle screw, the lower part remained in the patient.Infromations received 04-jul-2023.In total, the patient had been treated with 6 pedicle screws in may 2021, and the revision surgery was performed without any problems.The examinations revealed a product conforming to specifications with a permanent fracture.The possibility of screw fracture is well known in the market and mentioned in the ifu and in the patient information provided by signus as an undesirable side effect.We could not gain more patient-data and informations from the hospital.An undesirable side effect must not be reported in the eu.

• Brand Name: DIPLOMAT PEDICLE SCREW
• Type of Device: PEDICLE SCREW
• Manufacturer (Section D): SIGNUS MEDIZINTECHNIK GMBH; industriestrasse 2; alzenau, 63755 ; GM 63755
• Manufacturer (Section G): PROCON MEDIZINTECHNIK GMBH; industriegebiet süd e 8; alzenau, ; GM
• Manufacturer Contact: barbara peter ; industriestrasse 2; alzenau, 63755 ; GM 63755
• MDR Report Key: 18903834
• MDR Text Key: 337665849
• Report Number: 1000615957-2024-00002
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 04047844019436
• UDI-Public: 04047844019436
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K151704
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AB0321-75040
• Device Catalogue Number: AB0321-75040
• Device Lot Number: BA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2021
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female