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

Model Number	AB0010-55001
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/02/2023
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: 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
• Report Number: 1000615957-2024-00003
• Device Sequence Number: 20804957
• Product Code: NKB
• UDI-Device Identifier: 04047844020043
• UDI-Public: 04047844020043
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K151704
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/07/2024

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: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2023
• Initial Report FDA Received Date: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DIPLOMAT PEDICLE SCREW (REF & LOT UNKOWN)
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 42 YR
• Patient Sex: Male