MAUDE Adverse Event Report: SIGNUS MEDIZINTECHNIK GMBH DIPLOMAT; DIPLOMAT SET SCREW T30 Ø9.7X4.2MM

Model Number	DIPLOMAT
Medical Device Problem Codes	Mechanical Problem (1384); Unintended System Motion (1430); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923); Unintended Movement (3026)
Health Effect - Clinical Codes	No Code Available (3191); Missing Value Reason (3192)
Date of Event	05/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Summary: the complaint of the tulip and set screw is not justified.The claimed tulip and screw have no functional or structural deficits.A secure attachment of the rod is possible with the product without restriction.There are no additional, previously unknown risks.Due to the existing findings loosening of the set screw is a result of mishandling during the first implantation surgery.
Event or Problem Description
Post op images of the patient showed that a set screw had loosened from the tulip and could be seen next to the screw / rod combination.Due to the loosened locking screw, a revision surgery of 2 hours duration was required after one week.For reasons of data protection, the clinic did not provide radiographs and patient data.

• Brand Name: DIPLOMAT
• Common Device Name: DIPLOMAT SET SCREW T30 Ø9.7X4.2MM
• Manufacturer (Section D): SIGNUS MEDIZINTECHNIK GMBH; industriestrasse 2; alzenau, 63755 ; GM 63755
• MDR Report Key: 8643802
• Report Number: 9615021-2019-00004
• Device Sequence Number: 13524134
• Product Code: NKB
• UDI-Device Identifier: 04047844020067
• UDI-Public: 04047844020067
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/27/2019

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: DIPLOMAT
• Device Catalogue Number: AB0140-55000
• Device Lot Number: DL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2019
• Initial Report FDA Received Date: 05/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention