MAUDE Adverse Event Report: SIGNUS MEDIZINTECHNIK GMBH DIPLOMAT PEDICLE SCREW

Model Number	AB0321-75040
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/24/2023
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: 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
• Report Number: 1000615957-2024-00002
• Device Sequence Number: 21116167
• Product Code: NKB
• UDI-Device Identifier: 04047844019436
• UDI-Public: 04047844019436
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K151704
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/14/2024

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2023
• Initial Report FDA Received Date: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female