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DIPLOMAT Set screw T30Recalls & reported problems

SIGNUS Medizintechnik GmbH · The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or more screws via the screw head and a rod using a force-fit or form-fit connection. Additional fixation elements, such as cross bars, hooks, connectors and washers, can also be used. The DIPLOMAT® pedicle screw system is applied temporarily to provide internal posterior stabilization until bone fusion in the lumbar or thoracic spine has taken place. The surgeon makes the final decision as to the indwelling time of the implant in the patient‘s body and the time when the implant is to be explanted. The pedicle screw system is implanted from a posterior approach. The implant is screwed into the vertebral body via the pedicle and it can be applied in a single segment or multiple segments. Implantation is facilitated by use of the specially developed accessories for inserting and positioning the implants. Only these accessories ensure safe use. Our product information provides further system-related information on the surgical method. If there are any preoperative uncertainties relating to the implant, information must be obtained from SIGNUS. Instruments specially developed by SIGNUS to ensure safe application are available for use with the implant system. · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04047844020067), received between May 27, 2019 and May 27, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Detachment of Device or Device Component1
  • Device Dislodged or Dislocated1
  • Improper or Incorrect Procedure or Method1
  • Mechanical Problem1
  • Unintended Movement1
  • Unintended System Motion1
  • Use of Device Problem1

Patient problems

  • Missing Value Reason1
  • No Code Available1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 27, 2019Mechanical Problem; Unintended System Motion; Use of Device Problem; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Device Dislodged or Dislocated; Unintended Movement; Mechanical Problem; Unintended System Motion; Use of Device Problem; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Device Dislodged or Dislocated; Unintended Movement

    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.

    Patient problems: Missing Value Reason; No Code Available

    MAUDE report 8643802 ↗

Other Orthosis, Spondylolisthesis Spinal Fixation devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.