XIA IIRecalls & reported problems across all models
Stryker Corporation · 34 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 110
- Deaths reported
- 0
- Injuries reported
- 55
- Recalls
- 0
We found 34 models of XIA II by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 110 adverse event reports in the FDA's MAUDE database, received between Feb 16, 2016 and Oct 8, 2025 — classified as 55 injuries, 55 malfunctions.
The most frequently reported specific device problem is “Fracture” (56 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported XIA II problems
Device problems
- Fracture56
- Break54
- Material Integrity Problem16
- Device Dislodged or Dislocated15
- Device Slipped10
- Detachment of Device or Device Component9
- Mechanical Problem9
- Detachment Of Device Component7
Patient problems
- No Known Impact Or Consequence To Patient45
- Injury40
- Pain27
- No Clinical Signs, Symptoms or Conditions13
- No Code Available9
- No Information7
- No Consequences Or Impact To Patient6
- Reaction5
XIA II models
34 models, most reported first. Each model has its own page with its reports, recalls and device details.
- XIA II 03756230APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY27 reports
- XIA II 03822601APPLIANCE, FIXATION, SPINAL INTERLAMINAL13 reports
- XIA II 03820645Orthosis, spinal pedicle fixation, for degenerative disc disease6 reports
- XIA II 03802480ORTHOSIS, SPINAL PEDICLE FIXATION5 reports
- XIA II 03821540ORTHOSIS, SPINAL PEDICLE FIXATION5 reports
- XIA II 03821640APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY5 reports
- XIA II 03821645Orthosis, spinal pedicle fixation, for degenerative disc disease5 reports
- XIA II 03828645APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY4 reports
- XIA II 03829650APPLIANCE, FIXATION, SPINAL INTERLAMINAL4 reports
- XIA II 03820650ORTHOSIS, SPINAL PEDICLE FIXATION3 reports
- XIA II 03821545ORTHOSIS, SPINAL PEDICLE FIXATION3 reports
- XIA II 03820101Orthosis, spinal pedicle fixation, for degenerative disc disease2 reports
- XIA II 03821650Orthosis, spinal pedicle fixation, for degenerative disc disease2 reports
- XIA II 03821740APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- XIA II 03821750ORTHOSIS, SPINAL PEDICLE FIXATION2 reports
- XIA II 03821755APPLIANCE, FIXATION, SPINAL INTERLAMINAL2 reports
- XIA II 03821700ORTHOSIS, SPINAL PEDICLE FIXATION2 reports
- XIA II 03829645APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- XIA II 03820540ORTHOSIS, SPINAL PEDICLE FIXATION1 report
- XIA II 03820640APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- XIA II 03821635ORTHOSIS, SPINAL PEDICLE FIXATION1 report
- XIA II 03821655ORTHOSIS, SPINAL PEDICLE FIXATION1 report
- XIA II 03821745Orthosis, spinal pedicle fixation, for degenerative disc disease1 report
- XIA II 48218045APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- XIA II 48218050Orthosis, spondylolisthesis spinal fixation1 report
- XIA II 03820133APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- XIA II 03828640APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- XIA II 03829545APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- XIA II 03829630APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- XIA II 03829640Orthosis, spinal pedicle fixation, for degenerative disc disease1 report
- XIA II 48040150ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- XIA II 48041311ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- XIA II 48041313ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- XIA II 48047033ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
Recent XIA II adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryOct 8, 2025Fracture; Fracture
A CUSTOMER REPORTED THAT A XIA MONOAXIAL SCREW WAS OBSERVED TO HAVE FRACTURED APPROXIMATELY NINE YEARS POST-OPERATIVELY. THE PATIENT REPORTED EXPERIENCING A SORE WAIST AND WAS HOSPITALIZED FOR OBSERVATION AND "CONSERVATIVE TREATMENT". REVISION SURGERY HAS NOT TAKEN PLACE NOR BEEN SCHEDULED.
Patient problems: Discomfort
MAUDE report 23245007 ↗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 ↗MalfunctionJul 1, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING A SCHEDULED REVISION SURGERY TO REMOVE IMPLANTS IT WAS NOTICED THAT THE TIP OF A PREVIOUSLY IMPLANTED XIA POLYAXIAL SCREW AT L5 LEFT HAD FRACTURED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE TIP WAS LEFT IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19645133 ↗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 ↗InjuryJan 5, 2024Fracture; Fracture
A PATIENT UNDERWENT REVISION SURGERY TO ADDRESS A XIA POLYAXIAL SCREW FRACTURE ON THE LEFT SIDE OF L5. THE PATIENT REPORTED BACK PAIN AFTER 18 MONTHS FROM THE INITIAL SURGERY, AND SUBSEQUENT IMAGING IDENTIFIED THE FRACTURED SCREW.
Patient problems: Pain
MAUDE report 18460590 ↗InjuryAug 31, 2023Fracture; Fracture
A PATIENT UNDERWENT REVISION SURGERY TO ADDRESS A FRACTURED XIA LP MONOAXIAL SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17667180 ↗MalfunctionApr 5, 2023Fracture; Fracture
A COMPANY REPRESENTATIVE REPORTED THAT A XIA POLYAXIAL REDUCTION SCREW FRACTURED APPROXIMATELY 1 YEAR AND 1 MONTH POST-OPERATIVELY. REVISION SURGERY HAS NOT TAKEN PLACE NOR BEEN SCHEDULED. NO ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16684179 ↗MalfunctionMar 25, 2022Material Separation; Detachment of Device or Device Component; Material Deformation; Material Separation; Detachment of Device or Device Component; Material Deformation
IT WAS REPORTED THAT THE TULIP OF A XIA II LP POLYAXIAL SCREW DISENGAGED INTRA-OPERATIVELY. SURGERY WAS SUCCESSFULLY COMPLETED WITH ANOTHER SCREW AND NO DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13904721 ↗InjuryDec 10, 2021Fracture; Fracture
THE PATIENT WAS IMPLANTED WITH A XIA CONSTRUCT ON (B)(6) 2017. ON (B)(6) 2018, IT WAS REPORTED THAT THE TULIP OF A XIA 3 POLYAXIAL SCREW DISENGAGED AND THE RIGHT SIDE XIA II ROD FRACTURED AFTER THE PATIENT EXPERIENCED A FALL. ON (B)(6) 2021, IT WAS REPORTED THAT THE PATIENT HAD BEEN REVISED ON (B)(6) 2021 TO ADDRESS THE PREVIOUSLY REPORTED DISENGAGED SCREW AND FRACTURED ROD, AS WELL AS A SECOND ROD FRACTURE (ON THE LEFT SIDE). DURING REVISION SURGERY, A XIA 3 POLYAXIAL SCREW WAS NOTED TO BE LOOSE AND TWO XIA 3 MULTIAXIAL CROSSLINKS WERE REMOVED. EVALUATION OF THE RETURNED DEVICES IDENTIFIED THAT BOTH CROSSLINKS WERE FRACTURED. THIS RECORD CAPTURES THE SECOND FRACTURED XIA II VITALIUM ROD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12977777 ↗InjuryOct 27, 2021Fracture; Fracture
IT WAS REPORTED THAT TWO XIA II VITALIUM RODS FRACTURED AT L5/6 POST-OPERATIVELY. THE PATIENT WAS REVISED TO REPLACE THE FRACTURED RODS AND RE-FIX THE CONSTRUCT. THIS RECORD CAPTURES THE SECOND OF THE TWO XIA II VITALIUM RODS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12704490 ↗InjuryOct 27, 2021Fracture; Fracture
IT WAS REPORTED THAT TWO XIA II VITALIUM RODS FRACTURED AT L5/6 POST-OPERATIVELY. THE PATIENT WAS REVISED TO REPLACE THE FRACTURED RODS AND RE-FIX THE CONSTRUCT. THIS RECORD CAPTURES THE FIRST OF THE TWO XIA II VITALIUM RODS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12704484 ↗InjurySep 1, 2021Fracture; Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED PAIN AND IMAGING REVEALED A FRACTURED XIA LP POLYAXIAL SCREW, A FRACTURED XIA ROD, AND A XIA 3 TITANIUM POLYAXIAL SCREW WITH "HEAD PULL OUT." THE PATIENT UNDERWENT REVISION SURGERY. THE BODY OF THE XIA 3 TITANIUM POLYAXIAL SCREW WAS NOT ABLE TO BE REMOVED AND REMAINS IMPLANTED IN THE PATIENT'S ILLIUM. THIS REPORT CAPTURES THE FRACTURED XIA II ROD.
Patient problems: Pain
MAUDE report 12407887 ↗InjurySep 1, 2021Fracture; Material Separation; Detachment of Device or Device Component; Fracture; Material Separation; Detachment of Device or Device Component
IT WAS REPORTED THAT A PATIENT EXPERIENCED PAIN AND IMAGING REVEALED A FRACTURED XIA II LP POLYAXIAL SCREW, A FRACTURED XIA II ROD, AND A XIA 3 TITANIUM POLYAXIAL SCREW WITH "HEAD PULL OUT." THE PATIENT UNDERWENT REVISION SURGERY. THE BODY OF THE XIA 3 TITANIUM POLYAXIAL SCREW WAS NOT ABLE TO BE REMOVED AND REMAINS IMPLANTED IN THE PATIENT'S ILIUM. THIS REPORT CAPTURES THE XIA II LP SCREW.
Patient problems: Pain
MAUDE report 12407757 ↗
Other Stryker Corporation products
- RemB7 models · 3,073 reports
- Prime Series21 models · 1,548 reports · 2 recalls
- TARGET114 models · 1,077 reports
- ProCuity17 models · 368 reports · 13 recalls
- Spetzler-Malis20 models · 7 reports · 19 recalls
- SYNCHRO 28 models · 313 reports · 9 recalls
- Neptune E-SEP19 models · 412 reports · 7 recalls
- StrykeFlow4 models · 552 reports · 4 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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