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

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.

• Brand Name: DIPLOMAT
• Type of Device: DIPLOMAT 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 Key: 8643802
• MDR Text Key: 146378068
• Report Number: 9615021-2019-00004
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 04047844020067
• UDI-Public: 04047844020067
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K151704
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• 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 Received: 05/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 05/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention