MAUDE Adverse Event Report: SIGNUS MEDIZINTECHNIK GMBH DIPLOMAT; PERCUTANEOUS TULIP

Model Number	AB0030-55001
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Surgeon reported about the post-surgery x-ray for a 2 level mis case ( l4-l5-s1) using diplomat.The x-ray film indicates that the diplomat mis tulip was not attached to the pedicle screw head at s1 position.There was no difficulty reported during the operation.The patient was reported with little pain (possible causes are surgery or detached implant).Disassembly of implant components and pain areknown risks/side effects indicated in the ifu.

• Brand Name: DIPLOMAT
• Common Device Name: PERCUTANEOUS TULIP
• 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: 18901900
• Report Number: 1000615957-2024-00001
• Device Sequence Number: 20804958
• Product Code: NKB
• UDI-Device Identifier: 04047844023778
• UDI-Public: 04047844023778
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: K151704
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/01/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: AB0030-55001
• Device Catalogue Number: AB0030-55001
• Device Lot Number: LH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2023
• Initial Report FDA Received Date: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown
• Patient Race: Asian