XIA PRECISION 48230231Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327265286), received between Jul 25, 2016 and May 3, 2018 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (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 16, 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.

• MalfunctionMay 3, 2018Fracture; Break; Fracture; Difficult to Remove

  IT WAS REPORTED MIS-TLIF WAS DONE AT L4/L5/S1. AFTER THE SCREW WAS INSERTING TO RIGHT L5 OVER K WIRE WITH POWER TOOL, THE K WIRE WAS NOT ABLE TO BE REMOVED. THEREFORE, IT WAS REMOVED WITH PLIERS. AFTER THAT, THE SURGEON CONFIRMED THE TIP OF THE K WIRE WAS LEFT IN VERTEBRAL BODY UNDER X-P. FINALLY, THE NEW SCREW WAS INSERTED AND THE OPERATION WAS FINISHED. NO ADVERSE CONSEQUENCES TO THE PATIENT IS REPORTED.

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

  MAUDE report 7483101 ↗
• MalfunctionSep 29, 2017Mechanical Problem; Material Twisted/Bent; Mechanical Jam; Mechanical Problem; Mechanical Jam

  IT WAS REPORTED THAT; THE OR MANAGER AT THE HOSPITAL REPORTED TO THE SALES REP THE FOLLOWING EVENT : " THE EVENT OCCURED DURING A SURGERY ON L4-L5 ON A (B)(6) YEARS-OLD PATIENT PERFORMED. PATIENT INSTALLATION AND POSITIONING PREPARATION OF PEDICULAR AIMING IN L4 AND L5 WITH JAM SHIDI TROCAR INSERTION OF THE SPINDLE THROUGH THE JAM SHIDI TROCAR REMOVAL OF JAM SHIDI TROCARS BY LEAVING THE PINS ON THE PATIENT USE THE SQUARE TIP AND THE TAP BEFORE INSTALLING THE SCREW ON THE SCREWDRIVER AND THEN INSERT ON THE PATIENT. WHEN REMOVING THE PIN FROM THE SCREW, THE SURGEON FEELS A RETENTION OF THE PIN TO COME OUT. THE X-RAY CONFIRMS THAT THE SPINDLE IS TWISTED. THE SURGEON CAN NOT REMOVE THE PATIENT'S SPINDLE ALONE. THEREFORE, IT REMOVES THE SCREW WITH THE PIN. TO COMPLETE THE PROCEDURE, THE SURGEON DECIDES TO MAKE A PEDICLE WITH THE JAM SHIDI TROCAR AGAIN, INSERTING A NEW SPINDLE AND THEN INSERTING THE SCREW.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6904736 ↗
• MalfunctionJul 26, 2016Difficult to Insert; Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT; DURING (L4/5, L5/S1 MIS-PLIF) SURGERY, A PROGRESS OF A SCREW HAS STOPPED WHEN THE SURGEON WAS INSERTING THE SCREW TO L4 LEFT THROUGH A K-WIRE. THE K-WIRE DID NOT BE REMOVED FROM THE SCREW, SO THE SURGEON REMOVED THE K-WIRE AND THE SCREW TOGETHER. THEN, THE SURGEON INSERTED THE OTHER SCREW THROUGH THE OTHER K-WIRE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5821841 ↗
• MalfunctionJul 25, 2016Bent; Difficult to Insert

  IT WAS REPORTED THAT DURING AN OPEN SURGERY, THE SURGEON INSERTED A SCREW WITHOUT A K-WIRE AFTER THE TAPPING. BUT THE SCREW DID NOT PROCEED ALONG THE ORBIT OF THE TAP. THEN, THE SURGEON WAS INSERTED THE SAME SCREW THROUGH THE K-WIRE AGAIN. BUT THE K-WIRE WAS BENT EXCESSIVELY AND STACKED IN THE SCREW. THE SURGEON USED A NEW K-WIRE AND A NEW SCREW, AND PROGRESSED THE SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5821061 ↗