DIPLOMAT Percutaneous tulipRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04047844023778), received between Apr 30, 2019 and Mar 14, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Misassembled” (2 reports).

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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 14, 2024Material Twisted/Bent; Material Twisted/Bent

  SURGEON REPORTED ABOUT THE POST-SURGERY X-RAY FOR A 2 LEVEL MIS CASE ( L4-L5-S1) USING DIPLOMAT . THE X-RAY FILM INDICATES THAT THE DIPLOMAT MIS TULIP WAS NOT ATTACHED TO THE PEDICLE SCREW HEAD AT S1 POSITION. THERE WAS NO DIFFICULTY REPORTED DURING THE OPERATION. THE PATIENT WAS REPORTED WITH LITTLE PAIN (POSSIBLE CAUSES ARE SURGERY OR DETACHED IMPLANT). DISASSEMBLY OF IMPLANT COMPONENTS AND PAIN AREKNOWN RISKS/SIDE EFFECTS INDICATED IN THE IFU.

  Patient problems: Pain

  MAUDE report 18901900 ↗
• MalfunctionApr 30, 2019Misassembled; Use of Device Problem; Misassembly by Users; Misassembled; Use of Device Problem; Misassembly by Users

  AFTER SEVERAL COMPLAINTS ABOUT BENT MOBIS INSERTERS BECAUSE OF IMPROPER USE OF THE DEVICE AN APPLIED PRACTICE (AP31) WAS ADDED TO PRODUCT INFORMATION.

  Patient problems: No Code Available

  MAUDE report 8564023 ↗
• MalfunctionApr 30, 2019Misassembled; Use of Device Problem; Misassembly by Users; Misassembled; Use of Device Problem; Misassembly by Users

  REVISION SURGERY BECAUSE OF IMPROPER APPLICATION OF THE TULIP ON THE SCREW BY THE SURGEON WITHIN THE INITIAL SURGERY. THE PEDICLE SCREW NEVER WAS PROPERLY CONNECTED TO THE TULIP. THE FLAWED IMAGE OF THE TULIP'S HIGHLY INWARD-POINTING PLATE CLEARLY INDICATES THAT THE HEAD OF THE PEDICLE SCREW WAS NOT FIRMLY ATTACHED TO THE TULIP SADDLE. THE CONTROL OF THE TIGHTNESS OF THE TULIP ON THE PEDICLE SCREW DESCRIBED IN THE SURGICAL GUIDE WAS PROBABLY NOT DONE. THE SAME EFFECT OCCURS WHEN THE TULIP IS PLACED IN SITU AFTER THE PEDICLE SCREW HAS BEEN SET. IT INDICATES THAT THE PEDICLE SCREW WAS INSERTED QUITE DEEPLY INTO THE PEDICLE, SO THAT A COMPLETE GRASPING OF THE TULIP PLATELETS AROUND THE PEDICLE HEAD WAS NOT POSSIBLE DURING THE SUBSEQUENT PLACEMENT OF THE TULIP. THE INCORRECT PLACEMENT OF THE TULIP ON THE SCREW HEAD CAN THUS LEAD ALREADY DURING THE ATTACHMENT OF THE ROD FOR PUSHING OUT OF THE PEDICLE HEAD OF THE TULIP. THE HEAD OF THE PEDICLE SCREW THEN VERY PROBABLY BENT THE LEAFLETS OF THE TULIP'S SADDLE WHEN MOBILIZING THE PATIENT AND LATER SLIPPED OUT OF THE TULIP. BY OVERLAYING THE TULIPS AND PEDICLE SCREWS IN THE X-RAY IMAGE IN LATERAL VIEW, THIS SLIPPING OUT WAS NOT RECOGNIZED BY

  Patient problems: No Code Available

  MAUDE report 8563936 ↗
• MalfunctionApr 30, 2019Device Slipped

  LITERATURE "EXPERIENCE WITH A MODULAR PEEK SYSTEM FOR CERVICAL VERTEBRAL BODY REPLACEMENT" BY KONIG SA1, SPETZGER U REPORTED. "THE AUTHORS PERFORMED 13 ONE-LEVEL AND 7 TWO-LEVEL CORPECTOMIES; FROM THE LETTER GROUP THERE WERE 2 REVISION CASES (10%) WITH IMPLANT DISLOCATION. FOUR CASES (20%) OF SECONDARY SUBSIDENCE ..." THE STATEMENT (KÖNIG ET AL.2015) MADE BY THE AUTHORS CANNOT BE RECONSTRUCTED FROM THE DATA AVAILABLE HERE. FURTHER DATA ARE NECESSARY FOR AN OBJECTIVE ASSESSMENT. FIRST, THE AUTHORS WOULD HAVE HAD TO CHANGE THE STRUCTURE OF THEIR RETROSPECTIVE CASE SERIES. IN THE RETROSPECTIVE CASE SERIES DESCRIBED HERE, THE PATIENTS WERE DIVIDED INTO 2 GROUPS. THE FIRST GROUP CONSISTS OF 13 PATIENTS WITH A 1 LEVEL CORPECTOMY WERE PERFORMED. THE SECOND GROUP CONSISTS OF 7 PATIENTS IN WHOM A 2-LEVEL CORPECTOMY WAS PERFORMED. IN ALL CASES THE IMPLANT ATHLETE WAS USED. IN ORDER TO MAKE AN OBJECTIVE ASSESSMENT, THE AUTHORS WOULD HAVE HAD TO COMPARE THE RESULTS OF THE SAME NUMBER OF PATIENTS PER GROUP WITH THE ATHLETE IMPLANT AND FOR EXAMPLE WITH THE ILIAC CREST. THE NUMBER OF 20 PATIENTS IS ALSO TOO SMALL TO MAKE A SIGNIFICANT STATEMENT. IN THE SUMMARIES OF THE FOLLOWING PUBLICATIONS, WHI

  Patient problems: Failure of Implant

  MAUDE report 8563851 ↗