DIPLOMAT Pedicle screw w/o tulip, fenestrated, polyaxialRecalls & 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
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 04047844019436), received between Mar 14, 2024 and Mar 14, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture1
- Material Integrity Problem1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 14, 2024Fracture; Material Integrity Problem; Fracture; Material Integrity Problem
PEDICLE SCREW BROKEN, THIS WAS REMOVED DURING REVISION SURGERY. THIS INCIDENT WAS REPORTED BY THE SAFETY OFFICER OF THE CLINIC WITHOUT FURTHER INFORMATION. IT WAS VERY DIFFICULT TO OBTAIN INFORMATIONS ABOUT THE EVENT, AS WELL AS THE PATIENT'S CONSENT FORM FOR EXAMINATION OF THE EXPLANT - SCREW HEAD WITH UPPER PART OF THE PEDICLE SCREW, THE LOWER PART REMAINED IN THE PATIENT. INFROMATIONS RECEIVED 04-JUL-2023. IN TOTAL, THE PATIENT HAD BEEN TREATED WITH 6 PEDICLE SCREWS IN MAY 2021, AND THE REVISION SURGERY WAS PERFORMED WITHOUT ANY PROBLEMS. THE EXAMINATIONS REVEALED A PRODUCT CONFORMING TO SPECIFICATIONS WITH A PERMANENT FRACTURE. THE POSSIBILITY OF SCREW FRACTURE IS WELL KNOWN IN THE MARKET AND MENTIONED IN THE IFU AND IN THE PATIENT INFORMATION PROVIDED BY SIGNUS AS AN UNDESIRABLE SIDE EFFECT. WE COULD NOT GAIN MORE PATIENT-DATA AND INFORMATIONS FROM THE HOSPITAL. AN UNDESIRABLE SIDE EFFECT MUST NOT BE REPORTED IN THE EU.
Patient problems: Insufficient Information
MAUDE report 18903834 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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