MAUDE Adverse Event Report: SIGNUS MEDIZINTECHNIK GMBH DIPLOMAT; PEDICLE SCREW

Model Number AB0010-55001

Device Problem Fracture (1260)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/02/2023

Event Type  malfunction  

Event Description

The patient was operated with diplomat pedicle screw system (b)(6) 2022, two level surgery l4- l5- s1.He noticed some noise in his back.A check revealed broken pedicle screws which were surgically removed (b)(6) 2023.Fracture of implant components is a known risk indicated in the ifu.

• Brand Name: DIPLOMAT
• Type of Device: PEDICLE SCREW
• Manufacturer (Section D): SIGNUS MEDIZINTECHNIK GMBH; industriestrasse 2; alzenau, bavaria 63755 ; GM 63755
• Manufacturer (Section G): PROCON MEDIZINTECHNIK GMBH; industriegebiet sued e8; alzenau, bavaria 63755 ; GM 63755
• Manufacturer Contact: barbara peter ; industriestrasse 2; alzenau, bavaria 63755 ; GM 63755
• MDR Report Key: 18901899
• MDR Text Key: 337800475
• Report Number: 1000615957-2024-00003
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 04047844020043
• UDI-Public: 04047844020043
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K151704
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/07/2024

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: AB0010-55001
• Device Catalogue Number: AB0010-55001
• Device Lot Number: IV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2023
• Date Manufacturer Received: 11/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DIPLOMAT PEDICLE SCREW (REF & LOT UNKOWN)
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 42 YR
• Patient Sex: Male