XIA PRECISION SYSTEM 48237105Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327265705), received between Dec 2, 2016 and Dec 12, 2016 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2016Fracture; Material Integrity Problem; Break; Detachment Of Device Component; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT; NEUROSURGEON AT THE HOSPITAL, REPORTED THE FOLLOWING EVENT: "THE INSTRUMENTS WERE USED TO PERFORM A 4 PEDICULAR TARGETINGS (LEVELS L4-L5 TREATED). THE 4 TARGETINGS WERE CARRIED OUT ONE AFTER THE OTHER. FOR EACH TARGETING, THE GAUGE WAS INSERTED UNDER SCOPIC CONTROL TO ENSURE PROPER POSITIONING INTO THE PEDICLE. A HAMMER WAS USED BY THE SURGEON TO ADVANCE THE NEEDLE INTO THE PEDICLE. THE NEEDLE HAS AN INTERNAL FACET STYLUS THAT NEEDS TO BE REMOVED WHEN THE NEEDLE IS CORRECTLY POSITIONED. AS REQUIRED BY THE OPERATIVE PROCEDURE, THE SURGEON THEN INSERTED A NITINOL PIN INTO THE CANNULATED NEEDLE AFTER REMOVAL OF THE INTERNAL STYLET. ONCE THE PIN WAS INSERTED, THE NEEDLE HAS BEEN REMOVED FROM THE PATIENT. WHEN SURGEON REMOVED THE NEEDLE FROM THE FIRST PEDICLE, HE NOTED THAT 2 "TEETH" FROM THE DISTAL END WERE BROKEN AND THUS REMAINED IN THE PATIENT'S BONE. FOR THE SECOND PEDICLE, THE SURGEON USED A NEW GAUGE. UPON REMOVAL, THE SURGEON AGAIN OBSERVED THAT "2 TEETH" OF THE NEEDLE WERE BROKEN. A NEW GAUGE WAS USED BY THE SURGEON FOR THE 2 LAST PEDICULAR SHOTS (THE SAME FOR BOTH SIGHTINGS). THE REST OF THE SURGERY WAS COMPLETED NORMALLY." DUE TO THIS EVENT, THERE WAS A

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 6166319 ↗
• MalfunctionDec 12, 2016Fracture; Material Integrity Problem; Break; Detachment Of Device Component; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT; NEUROSURGEON AT THE HOSPITAL, REPORTED THE FOLLOWING EVENT: "THE INSTRUMENTS WERE USED TO PERFORM A 4 PEDICULAR TARGETING'S (LEVELS L4-L5 TREATED). THE 4 TARGETING'S WERE CARRIED OUT ONE AFTER THE OTHER. FOR EACH TARGETING, THE GAUGE WAS INSERTED UNDER SCOPIC CONTROL TO ENSURE PROPER POSITIONING INTO THE PEDICLE. A HAMMER WAS USED BY THE SURGEON TO ADVANCE THE NEEDLE INTO THE PEDICLE. THE NEEDLE HAS AN INTERNAL FACET STYLUS THAT NEEDS TO BE REMOVED WHEN THE NEEDLE IS CORRECTLY POSITIONED. AS REQUIRED BY THE OPERATIVE PROCEDURE, THE SURGEON THEN INSERTED A NITINOL PIN INTO THE CANNULATED NEEDLE AFTER REMOVAL OF THE INTERNAL STYLET. ONCE THE PIN WAS INSERTED, THE NEEDLE HAS BEEN REMOVED FROM THE PATIENT. WHEN SURGEON REMOVED THE NEEDLE FROM THE FIRST PEDICLE, HE NOTED THAT 2 "TEETH" FROM THE DISTAL END WERE BROKEN AND THUS REMAINED IN THE PATIENT'S BONE. FOR THE SECOND PEDICLE, THE SURGEON USED A NEW GAUGE. UPON REMOVAL, THE SURGEON AGAIN OBSERVED THAT "2 TEETH" OF THE NEEDLE WERE BROKEN. A NEW GAUGE WAS USED BY THE SURGEON FOR THE 2 LAST PEDICULAR SHOTS (THE SAME FOR BOTH SIGHTINGS). THE REST OF THE SURGERY WAS COMPLETED NORMALLY." DUE TO THIS EVENT, THERE WAS

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 6166312 ↗
• MalfunctionDec 2, 2016Fracture; Break; Detachment Of Device Component; Fracture

  IT WAS REPORTED THAT; SURGEON AT THE CLINIC REPORTED USED A JAM SHIDIS PART NUMBER DURING A PERCUTANEOUS ARTHRODESIS. INSERTION OF 4 NEEDLES JAM SHIDIS INTO THE PEDICLES OF THE PATIENT SUCCESSIVELY. FOR EACH NEEDLE, RADIO SHOTS WERE MADE THROUGHOUT THE INSERTION TO ENSURE OPTIMAL ORIENTATION OF THE NEEDLE INTO THE PEDICLE. TO GET THE RIGHT GUIDANCE, THE JAM SHIDI NEEDLES NEEDED TO BE MOVE TOWARDS THE DESIRED DIRECTION AND ASSISTED BY THE X-RAY CONTROL. THE NEEDLES HAVE AN INTERNAL STYLET FACETS WHICH IS THEN REMOVED ONCE THE NEEDLE PERMANENTLY ORIENTED IN THE BONE TISSUE. THE SURGEON THEN HAD, ACCORDING TO THE OPERATIVE PROCEDURE, TO INSERT THE PINS INTO THE CANNULATED NEEDLES AFTER THE REMOVAL OF THE INTERNAL STYLUS. ONCE THE PINS WERE INSERTED, THE NEEDLES WERE WITHDRAWN ONE BY ONE FROM THE PATIENT. DURING THE REMOVAL OF THE NEEDLES, DR. OBSERVED THAT ONE OF THEM HAD ITS DISTAL PORTION WHERE A "TEETH" WAS CUT, AND THEREFORE REMAINED TRAPPED IN THE PATIENT'S BONE. THE PROCEDURE BEING PERFORMED PERCUTANEOUSLY, IT WAS NOT POSSIBLE FOR THE SURGEON TO PROCEED TO THE EXTRACTION OF THIS LITTLE PIECE OF METAL. THE PROCEDURE THEN CONTINUED NORMALLY. NO ADVERSE CONSEQUENCES, THE SURGERY WA

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 6142627 ↗