XIA 3 48230141Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04546540602312), received between Apr 6, 2016 and Jun 28, 2019 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 28, 2019Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Loose or Intermittent Connection; Loosening of Implant Not Related to Bone-Ingrowth

  PHYSICIAN REPORTED THAT TWO RODS WERE FRACTURED POST-OPERATIVELY (CONFIRMED VIA X-RAY). DURING REVISION SURGERY, THE PHYSICIAN NOTED THREE ROD-TO-ROD CONNECTORS WERE LOOSE. THE FRACTURED RODS AND LOOSE CONNECTORS WERE REPLACED. THIS RECORD REPRESENTS THREE OF THE THREE LOOSE ROD-TO-ROD CONNECTORS.¿

  Patient problems: Injury

  MAUDE report 8743888 ↗
• MalfunctionJun 27, 2019Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Loose or Intermittent Connection; Loosening of Implant Not Related to Bone-Ingrowth

  PHYSICIAN REPORTED THAT TWO RODS WERE FRACTURED POST-OPERATIVELY (CONFIRMED VIA X-RAY). DURING REVISION SURGERY, THE PHYSICIAN NOTED THREE ROD-TO-ROD CONNECTORS WERE LOOSE. THE FRACTURED RODS AND LOOSE CONNECTORS WERE REPLACED. THIS RECORD REPRESENTS TWO OF THE THREE LOOSE ROD-TO-ROD CONNECTORS.¿

  Patient problems: Injury

  MAUDE report 8740444 ↗
• MalfunctionJun 21, 2019Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Loose or Intermittent Connection; Loosening of Implant Not Related to Bone-Ingrowth

  PHYSICIAN REPORTED THAT TWO RODS WERE FRACTURED POST-OPERATIVELY (CONFIRMED VIA X-RAY). DURING REVISION SURGERY, THE PHYSICIAN NOTED THREE ROD-TO-ROD CONNECTORS WERE LOOSE. THE FRACTURED RODS AND LOOSE CONNECTORS WERE REPLACED. THIS RECORD REPRESENTS ONE OF THE THREE LOOSE ROD-TO-ROD CONNECTORS.¿

  Patient problems: Injury

  MAUDE report 8725066 ↗
• MalfunctionOct 3, 2018Loose or Intermittent Connection; Migration; Migration

  IT WAS REPORTED THAT A PATIENT ORIGINALLY HAD AN L3-S1 FUSION AND WAS BROUGHT BACK FOR AN EXTENSION OF METAL WORK PROCEDURE BACK IN (B)(6) 2018. THE PATIENT'S L3 SCREWS WERE REMOVED AND THE SURGEON PUT 2 MORE SCREWS INTO L2 AND CONNECTED THE EXISTING RODS TO 2 NEW RODS WITH 2 SIDE TO SIDE CONNECTORS. THEY WERE HAND TIGHTENED AS PER SURGICAL TECHNIQUE. THE PATIENT HAS COME BACK FOR A FOLLOW UP (COMPLETELY ASYMPTOMATIC) AND AN X-RAY INDICATED THAT THE CONNECTOR HAS BECOME LOOSE AND SLID DOWN THE ROD AND ROTATED. NO SURGERY IS PLANNED CURRENTLY. THERE ARE NO REPORTS OF ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7931881 ↗
• InjuryMay 5, 2017Detachment Of Device Component; Mechanical Problem; Device Dislodged or Dislocated; Mechanical Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT; PERFORMED A SURGERY ON A PATIENT BACK IN 2016 USING A THORACO-LUMBAR-ILIAC SCREWING FROM A CONSIGNMENT AND A LOANER FOR THE ILIAC PART. ON (B)(6) 2017, PERFORMED A REVISION SURGERY ON THIS PATIENT BY IMPLANTING A CAGE IN ANTERIOR AND IN POSTERIOR FOR A COMPRESSION LAYOUT. BETWEEN THESE 2 DATES, A STEM OF THE ILIAC SCREWING DETACHED FROM THE STEM-STEM CONNECTOR THAT MADE THE LINK WITH LUMBAR SCREWING. THE SURGEON TOOK THE OPPORTUNITY OF THE REVISION SURGERY TO PUT BACK THE ILIAC LUMBAR CONNECTION IN PLACE BY CHANGING THE STEM-STEM CONNECTOR AS WELL AS THE STEM.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 6548507 ↗
• MalfunctionApr 6, 2016Material Deformation; Material Deformation; Unintended Movement

  IT WAS REPORTED THAT THE SURGEON FACED AN ISSUE WHEN SCREWING THE CONNECTOR SCREWS. ONCE THE TIGHTENING WAS COMPLETED, HE NOTICED THAT THE CONNECTOR WAS STILL MOVING ON THE ROD. HE TRIED TO TIGHTEN MORE BUT THE CONNECTOR WAS STILL MOVING ON THE ROD. HE CHANGED THE SMALL SCREWS BUT THE CONNECTOR WAS STILL MOVING ON THE RODS. HE CHANGED THE CONNECTOR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5551958 ↗
• InjuryApr 6, 2016Device Dislodged or Dislocated; Device Slipped; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE SURGEON AT THE CLINIC, REPORTED THAT HE HAD TO PROCEED TO A REVISION SURGERY ONE MONTH AFTER THE INITIAL IMPLANTATION BECAUSE THE EXTERNAL ROD SLIPPED FROM THE JUNCTION CONNECTOR AND PARTED FROM IT. BOTH SIDES OF THE ASSEMBLY WERE CONCERNED.

  Patient problems: Injury; No Code Available

  MAUDE report 5551954 ↗