Guide Tube Pedicle Access Needle (1.8 mm) 55844ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04056481001049), received between Nov 12, 2018 and Nov 12, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K183605, K252562); they may or may not involve this specific model.

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

• MalfunctionNov 12, 2018Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  AN OPEN SURGERY FOR A T10 TO PELVIS EXTENSION FUSION INCLUDING AN ALAR-ILIAC JOINT SCREW PLACEMENT THROUGH S2, WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE SPINE&TRAUMA 3D 2.6, USING THE NAVIGATED PEDICLE ACCESS NEEDLE SET. DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT IN PRONE POSITION ON THE OR TABLE. PLACED K-WIRES AND PEDICLE SCREWS IN VERTEBRAE T10 TO L2 WITH THE NAVIGATION EQUIPMENT, AND PERFORMED A VERIFICATION SCAN TO CONFIRM INTENDED PLACEMENTS. CONTINUED WITH THE SECOND SECTION OF THE SURGERY, THE ALAR-ILIAC JOINT SCREW PLACEMENT THROUGH S2. USED THE NAVIGATED PEDICLE ACCESS GUIDE TUBE TO DETERMINE THE ENTRY POINT AND TRAJECTORY FOR THE JOINT SCREW, AND USED A MALLET TO INSERT THE PEDICLE ACCESS NEEDLE WITH TUBE CA. 7CM DEEP INTO THE PELVIC BONES THROUGH THE SI JOINT, PASSING TWO FURTHER CORTICAL BONE LAYERS. DETECTED DIRECTLY AFTER NEEDLE INSERTION, THAT THE DRILL GUIDE TUBE BECAME BENT, SLIGHTLY CURVED AT THE TIP BY CA. 5MM, LEADING TO A MISPLACEMENT OF THE INSERTED NEEDLE OF CA. 5MM FROM THE INTENDED POSITION IN THE BONE. USED ANOTHER DRILL GUIDE TUBE, REPEATED THE NEEDLE INSERTION AS ABOVE, AND AGAIN DETECTED THAT ALSO THIS

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8059165 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K183605, K252562. One submission often covers many models, so check the product and lot details in each record.

• Z-2925-2020 · Aug 20, 2020 · Terminated
  Cirq Arm System - Model SBS 1.3.2 (Art.No. 56000-01B) and SBS 1.4 (Art.No. 56000-01C) of the CIRQ Arm System (56000 and 56000A)
• Z-2793-2020 · Jul 16, 2020 · Terminated
  BRAINLAB Kick 2; Model/catalogue (article) numbers for Kick: 18170; 18070 UDI (GTIN) for Kick: 04056481006655
• Z-2792-2020 · Jul 16, 2020 · Terminated
  BRAINLAB Curve; Model/catalogue (article) numbers for Curve: 19901; 19901B; 19900; 19905 UDI (GTIN) for Curve: 04056481138011