• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SIGNUS MEDIZINTECHNIK GMBH DIPLOMAT DIPLOMAT SET SCREW T30 Ø9.7X4.2MM Back to Search Results
Model Number DIPLOMAT
Device Problems 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)
Patient Problems No Code Available (3191); Missing Value Reason (3192)
Event Date 05/09/2019
Event Type  malfunction  
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 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDIPLOMAT
Type of DeviceDIPLOMAT SET SCREW T30 Ø9.7X4.2MM
Manufacturer (Section D)
SIGNUS MEDIZINTECHNIK GMBH
industriestrasse 2
alzenau, 63755
GM 63755
Manufacturer Contact
frank oczkowski
industriestrasse 2
alzenau, bavaria 63755
GM   63755
MDR Report Key8643802
MDR Text Key146378068
Report Number9615021-2019-00004
Device Sequence Number1
Product Code NKB
UDI-Device Identifier04047844020067
UDI-Public04047844020067
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K151704
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 05/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberDIPLOMAT
Device Catalogue NumberAB0140-55000
Device Lot NumberDL
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/17/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/09/2019
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/27/2019 Patient Sequence Number: 1
-
-