XIA II 03756230Recalls & reported problems
Stryker Corporation · BLOCKER · Class 2 · Implant
Quick summary
This Stryker XIA II blocker is an implant used to hold spinal vertebrae steady during fusion surgery. The 27 reports mostly describe parts breaking or shifting out of place during surgery — cracked rods, blocks that migrated and had to be removed in revision surgery, and screw caps that were hard to release — along with back pain and bone that failed to fuse in a few cases. No deaths were reported, 8 reports involved injury, and 19 described malfunctions. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 27
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 04546540147257), received between Apr 19, 2016 and May 7, 2025 — classified as 8 injuries, 19 malfunctions.
The most frequently reported specific device problem is “Break” (13 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.
Reports received per month
Most reported problems
Device problems
- Break13
- Device Dislodged or Dislocated7
- Fracture7
- Device Slipped6
- Loose or Intermittent Connection4
- Material Integrity Problem4
- Migration4
- Mechanical Problem3
Patient problems
- No Known Impact Or Consequence To Patient15
- Injury8
- Pain4
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient3
- Nonunion/Delayed-union Bone Fracture3
- No Information2
- Reaction2
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
InjuryMay 7, 2025Migration; Migration
IT WAS REPORTED THAT A PATIENT WAS REVISED TO ADDRESS A FRACTURED XIA ROD AND A MIGRATED UNKNOWN SET SCREW. THIS REPORT CAPTURES THE UNKNOWN SET SCREW.
Patient problems: Insufficient Information
MAUDE report 21980885 ↗InjuryMar 15, 2024Migration; Migration
IT WAS REPORTED THAT A PATIENT WAS REVISED TO ADDRESS THREE MIGRATED XIA BLOCKERS. THIS CAPTURES THE THIRD OF THREE BLOCKERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18915384 ↗InjuryMar 15, 2024Migration; Migration
IT WAS REPORTED THAT A PATIENT WAS REVISED TO ADDRESS THREE MIGRATED XIA BLOCKERS. THIS CAPTURES THE SECOND OF THREE BLOCKERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18915378 ↗InjuryMar 15, 2024Migration; Migration
IT WAS REPORTED THAT A PATIENT WAS REVISED TO ADDRESS THREE MIGRATED XIA BLOCKERS. THIS CAPTURES THE FIRST OF THREE BLOCKERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18915377 ↗MalfunctionNov 21, 2018Positioning Problem; Device Slipped; Positioning Problem
IT WAS REPORTED THAT DURING SURGERY, SCREWS SLIPS OFF AFTER TIGHTEN HEXAGON THREAD USING CROWN-OPENER. TRYING TO LOOSEN IT AND RE-INSTALLED WOULD OCCUR A PROBLEM THAT HEXAGON THREAD BECOMING TOO SLIPPERY TO INSTALL. SURGERY WAS SUCCESSFULLY COMPLETED USING BACK-UP BLOCKERS. SURGICAL DELAY OF 5 MIN WAS REPORTED. NO ADVERSE CONSEQUENCE TO THE PATIENT WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 8094226 ↗MalfunctionNov 21, 2018Positioning Problem; Device Slipped; Positioning Problem
IT WAS REPORTED THAT DURING SURGERY, SCREWS SLIPS OFF AFTER TIGHTEN HEXAGON THREAD USING CROWN-OPENER. TRYING TO LOOSEN IT AND RE-INSTALLED WOULD OCCUR A PROBLEM THAT HEXAGON THREAD BECOMING TOO SLIPPERY TO INSTALL. SURGERY WAS SUCCESSFULLY COMPLETED USING BACK-UP BLOCKERS. SURGICAL DELAY OF 5 MIN WAS REPORTED. NO ADVERSE CONSEQUENCE TO THE PATIENT WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 8094072 ↗MalfunctionNov 21, 2018Positioning Problem; Device Slipped; Detachment of Device or Device Component; Positioning Problem
IT WAS REPORTED THAT DURING SURGERY, SCREWS SLIPS OFF AFTER TIGHTEN HEXAGON THREAD USING CROWN-OPENER. TRYING TO LOOSEN IT AND RE-INSTALLED WOULD OCCUR A PROBLEM THAT HEXAGON THREAD BECOMING TOO SLIPPERY TO INSTALL. SURGERY WAS SUCCESSFULLY COMPLETED USING BACK-UP BLOCKERS. SURGICAL DELAY OF 5 MIN WAS REPORTED. NO ADVERSE CONSEQUENCE TO THE PATIENT WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8094065 ↗MalfunctionJan 26, 2018Break; Fracture; Difficult to Remove; Fracture
I WAS REPORTED THAT WHEN DOCTOR USED 2 POLYAXIAL SCREWS AND 2 REDUCTION LONG ARM MONOAXIAL SCREWS. HE INSERTED THE SCREW ON THE LEFT OF S1. WHEN HE TRIED TO USE THE CAP INSERTER INSTRUMENT TO LOCK THE CAP INTO THE SCREW, HE FOUND THE CAP IS BROKEN. THERE IS A BROKEN LINE ON THE CAP. THE DOCTOR TRIED TO GET THE BROKEN CAP. OUT. HOWEVER, BECAUSE OF THE BROKEN LINE, THE CAP WAS BIGGER THAN THE HEAD OF THE CAP INSERTER, IT WAS HARD TO GET THE CAP OUT. FINALLY, AFTER ABOUT 40 MIN,HE USED THE CUTTER TO CUT THE CAP INTO PIECES AND GOT THE PIECES OUT, REINSERTED A NEW CAP.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7221018 ↗MalfunctionJun 20, 2017Fracture; Material Integrity Problem; Burst Container or Vessel; Crack; Fracture; Material Integrity Problem
IT WAS REPORTED THAT; DURING THE OPERATION, THE NUT BURST OCCURS WHEN THE NUT IS FINALLY LOCKED. EVENTUALLY THE DOCTOR CAN ONLY RESET THE STICK AND USE THE NEW PLUG TO LOCK IT. AFTER THE NUT IS IMPLANTED WITH THE SCREW, THE FINAL LOCKING IS NOT MADE, AND THE NUT APPEARS CRACK. ABOUT HALF AN HOUR SURGICAL DELAY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6655266 ↗MalfunctionApr 11, 2017Break; Material Deformation; Material Integrity Problem; Material Deformation; Material Integrity Problem
IT WAS REPORTED THAT; ONE CAP WAS BROKEN WHEN DOCTOR TRY TO USE TIGHTENER TO INSERT AND LOCK THE CAP
Patient problems: Injury; No Known Impact Or Consequence To Patient
MAUDE report 6482976 ↗MalfunctionApr 11, 2017Break; Fracture; Fracture
ONE CAP WAS BROKEN WHEN DOCTOR TRY TO USE TIGHTENER TO INSERT AND LOCK THE CAP
Patient problems: No Information; No Known Impact Or Consequence To Patient
MAUDE report 6482785 ↗MalfunctionApr 11, 2017Break; Fracture; Fracture
IT WAS REPORTED THAT; ONE CAP WAS BROKEN WHEN DOCTOR TRY TO USE TIGHTENER TO INSERT AND LOCK THE CAP
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6482780 ↗MalfunctionMar 15, 2017Break; Device Slipped; Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT: COBALT CHROME ROD BROKEN. BLOCKERS LOOSE AT T10, T11, L4, L5, S1, ILIAC BOLT AND OFFSET CONNECTOR. SCREW LOOSE AT LEFT S1. MULTIPLE LEVELS OF NONUNION. REPLACED ROD AND AFFECTED SCREWS.
Patient problems: Injury; Nonunion/Delayed-union Bone Fracture
MAUDE report 6408144 ↗MalfunctionMar 15, 2017Failure To Adhere Or Bond; Break; Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT: COBALT CHROME ROD BROKEN. BLOCKERS LOOSE AT T10, T11, L4, L5, S1, ILIAC BOLT AND OFFSET CONNECTOR. SCREW LOOSE AT LEFT S1. MULTIPLE LEVELS OF NONUNION. REPLACED ROD AND AFFECTED SCREWS.
Patient problems: Injury; Nonunion/Delayed-union Bone Fracture
MAUDE report 6408142 ↗MalfunctionMar 15, 2017Failure To Adhere Or Bond; Break; Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT: COBALT CHROME ROD BROKEN. BLOCKERS LOOSE AT T10, T11, L4, L5, S1, ILIAC BOLT AND OFFSET CONNECTOR. SCREW LOOSE AT LEFT S1. MULTIPLE LEVELS OF NONUNION. REPLACED ROD AND AFFECTED SCREWS.
Patient problems: Injury; Nonunion/Delayed-union Bone Fracture
MAUDE report 6408134 ↗MalfunctionMar 15, 2017Break; Loose or Intermittent Connection; Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT: COBALT CHROME ROD BROKEN. BLOCKERS LOOSE AT T10, T11, L4, L5, S1, ILIAC BOLT AND OFFSET CONNECTOR. SCREW LOOSE AT LEFT S1. MULTIPLE LEVELS OF NONUNION. REPLACED ROD AND AFFECTED SCREWS.
Patient problems: Injury; No Known Impact Or Consequence To Patient
MAUDE report 6408133 ↗MalfunctionMar 15, 2017Loss of or Failure to Bond; Break; Loose or Intermittent Connection; Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT: COBALT CHROME ROD BROKEN. BLOCKERS LOOSE AT T10, T11, L4, L5, S1, ILIAC BOLT AND OFFSET CONNECTOR. SCREW LOOSE AT LEFT S1. MULTIPLE LEVELS OF NONUNION. REPLACED ROD AND AFFECTED SCREWS.
Patient problems: Injury; No Known Impact Or Consequence To Patient
MAUDE report 6408131 ↗MalfunctionNov 18, 2016Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem
IT WAS REPORTED THAT DURING THE SURGERY BLOCKER WAS BROKEN DURING PRIMARY LOCKING. CLARIFICATION REQUESTED IS IN REGARDS WITH THE TORQUE WRENCH AND OVERTIGHTEN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6112613 ↗MalfunctionNov 14, 2016Break
IT WAS REPORTED THAT DURING THE SURGERY BLOCKER WAS BROKEN DURING PRIMARY LOCKING. CLARIFICATION REQUESTED IS IN REGARDS WITH THE TORQUE WRENCH AND OVERTIGHTEN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6099794 ↗InjurySep 1, 2016Biocompatibility; Insufficient Device Problem Information; Biocompatibility
IT WAS REPORTED THAT; PATIENT RECEIVED A POSTERIOR LUMBAR DECOMPRESSION INFUSION AT L4-L5 IN (B)(6) 2014. SHE RECENTLY STARTED TO EXPERIENCE A LOT OF ACHING AND PAIN AND HER SURGEON SUGGESTS THIS MAY BE AN ALLERGIC REACTION TO THE IMPLANT.
Patient problems: Pain; Reaction
MAUDE report 5920589 ↗InjurySep 1, 2016Biocompatibility; Insufficient Device Problem Information; Biocompatibility
IT WAS REPORTED THAT; PATIENT RECEIVED A POSTERIOR LUMBAR DECOMPRESSION INFUSION AT L4-L5 IN (B)(6) 2014. SHE RECENTLY STARTED TO EXPERIENCE A LOT OF ACHING AND PAIN AND HER SURGEON SUGGESTS THIS MAY BE AN ALLERGIC REACTION TO THE IMPLANT.
Patient problems: Pain; Reaction
MAUDE report 5920585 ↗MalfunctionJul 19, 2016Break; Fracture; Fracture
IT WAS REPORTED THAT; CUSTOMER REPORTED THAT THE BLOCKER BROKE IN THE SCREW AND THE EVENT WAS OBSERVED DURING SURGERY.
Patient problems: No Information; No Known Impact Or Consequence To Patient
MAUDE report 5803047 ↗InjuryMay 18, 2016Loose or Intermittent Connection; Mechanical Problem; Device Dislodged or Dislocated; Mechanical Problem; Device Dislodged or Dislocated
IT WAS REPORTED THAT; PATIENT EXPERIENCED LOW BACK PAIN. SURGEON SUSPECTED LOOSE PEDICLE SCREW BASED OFF OF SLIGHT RADIOLUCENCY VISIBLE AROUND LT L3 SCREW.
Patient problems: Injury; Pain
MAUDE report 5665000 ↗MalfunctionMay 18, 2016Loose or Intermittent Connection; Mechanical Problem; Device Dislodged or Dislocated; Mechanical Problem; Device Dislodged or Dislocated
IT WAS REPORTED THAT; PATIENT EXPERIENCED LOW BACK PAIN. SURGEON SUSPECTED LOOSE PEDICLE SCREW BASED OFF OF SLIGHT RADIOLUCENCY VISIBLE AROUND LT L3 SCREW.
Patient problems: Injury; Pain
MAUDE report 5664998 ↗MalfunctionApr 27, 2016Device Slipped
IT WAS REPORTED THAT THE DOCTOR FOUND THE SCREW SLIP DURING THE LUMBAR SPINE SURGERY AND COMPLETED THE SURGERY CHANGING TO ANOTHER ONE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5613437 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.