XIA 4 5 48130000Recalls & reported problems
Stryker Corporation · BLOCKER · Class 2 · Implant
Quick summary
This Stryker XIA 4.5 Blocker is a small implant used with polyaxial screws to hold spinal hardware in place. The 29 reports mostly describe parts loosening or shifting out of position after surgery, sometimes with the rod coming loose, which led to pain, injury and revision surgery in some cases; no deaths and 23 injuries were reported, along with 6 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
- 29
- Deaths reported
- 0
- Injuries reported
- 23
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 04546540448897), received between Feb 16, 2016 and Dec 15, 2025 — classified as 23 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Migration” (19 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
- Migration19
- Migration or Expulsion of Device6
- Connection Problem3
- Mechanical Problem3
- Device Dislodged or Dislocated2
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Detachment of Device or Device Component1
Patient problems
- Injury16
- No Clinical Signs, Symptoms or Conditions10
- No Known Impact Or Consequence To Patient6
- No Code Available3
- Failure of Implant1
- No Information1
- Pain1
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
InjuryDec 15, 2025Migration; Migration
A HEALTH PROFESSIONAL REPORTED THAT FOUR XIA 4.5 POLYAXIAL SCREWS AND FOUR XIA 4.5 BLOCKERS MIGRATED POST-OPERATIVELY. THE PATIENT WAS REVISED APPROXIMATELY ONE MONTH POST-OPERATIVELY. THIS REPORT CAPTURES THE FOURTH OF FOUR BLOCKERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23812753 ↗InjuryDec 15, 2025Migration; Migration
A HEALTH PROFESSIONAL REPORTED THAT FOUR XIA 4.5 POLYAXIAL SCREWS AND FOUR XIA 4.5 BLOCKERS MIGRATED POST-OPERATIVELY. THE PATIENT WAS REVISED APPROXIMATELY ONE MONTH POST-OPERATIVELY. THIS REPORT CAPTURES THE SECOND OF FOUR BLOCKERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23812720 ↗InjuryDec 15, 2025Migration; Migration
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23812719 ↗InjuryDec 15, 2025Migration; Migration
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23812691 ↗InjuryFeb 13, 2023Migration; Migration
IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY TO ADDRESS A MIGRATED XIA 4.5 BLOCKER AND XIA 4.5 POLYAXIAL SCREW APPROXIMATELY 3.5 MONTHS AFTER IMPLANTATION. THIS REPORT IS FOR THE XIA 4.5 BLOCKER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16369167 ↗MalfunctionMar 4, 2022Migration; Migration
A PHYSICIAN REPORTED THAT A XIA 4.5 TITANIUM BLOCKER AT S2 ON THE RIGHT SIDE HAS LOOSENED AND THE ROD, "IS ABOUT TO COME OFF." REVISION SURGERY HAS NOT OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13667409 ↗InjuryAug 25, 2021Migration; Migration
A PHYSICIAN REPORTED MIGRATION OF TWO XIA 4.5 BLOCKERS AND ONE TRITANIUM PL CAGE. THE PATIENT WAS REVISED APPROXIMATELY EIGHT WEEKS AFTER IMPLANTATION. ALL COMPONENTS OF THE CONSTRUCT WERE RETURNED. ANALYSIS OF THE ADDITIONAL FOUR XIA 4.5 BLOCKERS WHICH WERE RETURNED INDICATES THAT ALL SIX BLOCKERS IN THE CONSTRUCT WERE NOT APPROPRIATELY SECURED AND THEREFORE CONTRIBUTED TO THE MIGRATION OF THE RODS. THIS REPORT CAPTURES THE FOURTH OF SIX XIA 4.5 BLOCKERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12367052 ↗InjuryAug 25, 2021Migration; Migration
A PHYSICIAN REPORTED MIGRATION OF TWO XIA 4.5 BLOCKERS AND ONE TRITANIUM PL CAGE. THE PATIENT WAS REVISED APPROXIMATELY EIGHT WEEKS AFTER IMPLANTATION. ALL COMPONENTS OF THE CONSTRUCT WERE RETURNED. ANALYSIS OF THE ADDITIONAL FOUR XIA 4.5 BLOCKERS WHICH WERE RETURNED INDICATES THAT ALL SIX BLOCKERS IN THE CONSTRUCT WERE NOT APPROPRIATELY SECURED AND THEREFORE CONTRIBUTED TO THE MIGRATION OF THE RODS. THIS REPORT CAPTURES THE FIFTH OF SIX XIA 4.5 BLOCKERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12366662 ↗InjuryAug 25, 2021Migration; Migration
A PHYSICIAN REPORTED MIGRATION OF TWO XIA 4.5 BLOCKERS AND ONE TRITANIUM PL CAGE. THE PATIENT WAS REVISED APPROXIMATELY EIGHT WEEKS AFTER IMPLANTATION. ALL COMPONENTS OF THE CONSTRUCT WERE RETURNED. ANALYSIS OF THE ADDITIONAL FOUR XIA 4.5 BLOCKERS WHICH WERE RETURNED INDICATES THAT ALL SIX BLOCKERS IN THE CONSTRUCT WERE NOT APPROPRIATELY SECURED AND THEREFORE CONTRIBUTED TO THE MIGRATION OF THE RODS. THIS REPORT CAPTURES THE SIXTH OF SIX XIA 4.5 BLOCKERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12366661 ↗InjuryAug 25, 2021Migration; Migration
A PHYSICIAN REPORTED MIGRATION OF TWO XIA 4.5 BLOCKERS AND ONE TRITANIUM PL CAGE. THE PATIENT WAS REVISED APPROXIMATELY EIGHT WEEKS AFTER IMPLANTATION. ALL COMPONENTS OF THE CONSTRUCT WERE RETURNED. ANALYSIS OF THE ADDITIONAL FOUR XIA 4.5 BLOCKERS WHICH WERE RETURNED INDICATES THAT ALL SIX BLOCKERS IN THE CONSTRUCT WERE NOT APPROPRIATELY SECURED AND THEREFORE CONTRIBUTED TO THE MIGRATION OF THE RODS. THIS REPORT CAPTURES THE THIRD OF SIX XIA 4.5 BLOCKERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12366658 ↗InjuryApr 8, 2020Migration; Migration
IT WAS REPORTED THAT FOUR XIA TITANIUM 4.5 BLOCKERS DISENGAGED FROM THEIR RESPECTIVE SCREWS THREE YEARS POST-OPERATIVELY AND WERE DISCOVERED VIA X-RAY. REVISION SURGERY HAS OCCURRED. THIS RECORD REPRESENTS BLOCKER 2 OF 4.
Patient problems: Injury
MAUDE report 9936111 ↗InjuryApr 8, 2020Migration; Migration
IT WAS REPORTED THAT FOUR XIA TITANIUM 4.5 BLOCKERS DISENGAGED FROM THEIR RESPECTIVE SCREWS THREE YEARS POST-OPERATIVELY AND WERE DISCOVERED VIA X-RAY. REVISION SURGERY HAS OCCURRED. THIS RECORD REPRESENTS BLOCKER 3 OF 4.
Patient problems: Injury
MAUDE report 9936089 ↗InjuryApr 8, 2020Migration; Migration
IT WAS REPORTED THAT FOUR XIA TITANIUM 4.5 BLOCKERS DISENGAGED FROM THEIR RESPECTIVE SCREWS THREE YEARS POST-OPERATIVELY AND WERE DISCOVERED VIA X-RAY. REVISION SURGERY HAS OCCURRED. THIS RECORD REPRESENTS BLOCKER 4 OF 4.
Patient problems: Injury
MAUDE report 9936080 ↗InjuryApr 8, 2020Migration; Migration
IT WAS REPORTED THAT FOUR XIA TITANIUM 4.5 BLOCKERS DISENGAGED FROM THEIR RESPECTIVE SCREWS THREE YEARS POST-OPERATIVELY AND WERE DISCOVERED VIA X-RAY. REVISION SURGERY HAS OCCURRED. THIS RECORD REPRESENTS BLOCKER 1 OF 4.
Patient problems: Injury
MAUDE report 9936077 ↗InjuryMar 31, 2020Migration; Migration
IT WAS REPORTED THAT FOUR XIA TITANIUM 4.5 BLOCKERS DISENGAGED FROM THE RESPECTED SCREWS WITHIN 1 MONTH POST-OPERATIVELY. REVISION SURGERY HAS OCCURRED. THIS RECORD REPRESENTS BLOCKER 4 OF 4.
Patient problems: Injury
MAUDE report 9903699 ↗InjuryMar 31, 2020Migration; Migration
IT WAS REPORTED THAT FOUR XIA TITANIUM 4.5 BLOCKERS DISENGAGED FROM THE RESPECTED SCREWS WITHIN 1 MONTH POST-OPERATIVELY. REVISION SURGERY HAS OCCURRED. THIS RECORD REPRESENTS BLOCKER 3 OF 4.
Patient problems: Injury
MAUDE report 9903530 ↗InjuryMar 31, 2020Migration; Migration
IT WAS REPORTED THAT FOUR XIA TITANIUM 4.5 BLOCKERS DISENGAGED FROM THE RESPECTED SCREWS WITHIN 1 MONTH POST-OPERATIVELY. REVISION SURGERY HAS OCCURRED. THIS RECORD REPRESENTS BLOCKER 1 OF 4.
Patient problems: Injury
MAUDE report 9903413 ↗InjuryMar 31, 2020Migration; Migration
IT WAS REPORTED THAT FOUR XIA TITANIUM 4.5 BLOCKERS DISENGAGED FROM THE RESPECTED SCREWS WITHIN 1 MONTH POST-OPERATIVELY. REVISION SURGERY HAS OCCURRED. THIS RECORD REPRESENTS BLOCKER 2 OF 4.
Patient problems: Injury
MAUDE report 9903412 ↗InjuryMar 23, 2020Migration; Migration
IT WAS REPORTED THAT A XIA TITANIUM 4.5 BLOCKER MIGRATED LESS THAN 1 MONTH POST-OPERATIVELY. REVISION SURGERY HAS OCCURRED.
Patient problems: Injury
MAUDE report 9869255 ↗MalfunctionAug 22, 2017Mechanical Problem; Migration or Expulsion of Device; Mechanical Problem; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT; EXPLANTED RODS AND SET SCREWS.
Patient problems: Injury; No Code Available
MAUDE report 6811929 ↗InjuryAug 22, 2017Mechanical Problem; Migration or Expulsion of Device; Mechanical Problem; Migration or Expulsion of Device; Device Operates Differently Than Expected
IT WAS REPORTED THAT; EXPLANTED RODS AND SET SCREWS.
Patient problems: Failure of Implant; Injury; No Code Available
MAUDE report 6811845 ↗MalfunctionJun 27, 2017Migration or Expulsion of Device; Migration or Expulsion of Device; Connection Problem
IT WAS REPORTED THAT; SURGEON DISCOVERED ON (B)(6) 2017 THE RODS WERE NOT CONNECTED TO THE S1 SCREWS FROM A CASE WE DID ON (B)(6) 2017 WITH THE SCREW SYSTEM. WE ARE REDOING THE HARDWARE TO CONNECT THE RODS ON (B)(6) 2017. ON ORIGINAL SURGERY (B)(6) 2017 THE RODS WERE TORQUED DOWN IN CORRECT POSITION AT END OF CASE. PROCEDURE WAS COMPLETED AS PER THE TECHNIQUE GUIDE BUT WOULD LIKE THE TORQUE WRENCH TO BE EVALUATED TO MAKE SURE IT FUNCTIONED PROPERLY.
Patient problems: Injury; No Known Impact Or Consequence To Patient
MAUDE report 6671767 ↗MalfunctionJun 27, 2017Migration or Expulsion of Device; Migration or Expulsion of Device; Connection Problem
IT WAS REPORTED THAT; SURGEON DISCOVERED ON (B)(6) 2017 THE RODS WERE NOT CONNECTED TO THE S1 SCREWS FROM A CASE WE DID ON (B)(6) 2017 WITH THE SCREW SYSTEM. WE ARE REDOING THE HARDWARE TO CONNECT THE RODS ON (B)(6) 2017. ON ORIGINAL SURGERY (B)(6) 2017 THE RODS WERE TORQUED DOWN IN CORRECT POSITION AT END OF CASE. PROCEDURE WAS COMPLETED AS PER THE TECHNIQUE GUIDE BUT WOULD LIKE THE TORQUE WRENCH TO BE EVALUATED TO MAKE SURE IT FUNCTIONED PROPERLY.
Patient problems: Injury; No Known Impact Or Consequence To Patient
MAUDE report 6671680 ↗InjuryJun 27, 2017Migration or Expulsion of Device; Migration or Expulsion of Device; Connection Problem
IT WAS REPORTED THAT; SURGEON DISCOVERED ON (B)(6) 2017 THE RODS WERE NOT CONNECTED TO THE S1 SCREWS FROM A CASE WE DID ON (B)(6) 2017 WITH THE SCREW SYSTEM. WE ARE REDOING THE HARDWARE TO CONNECT THE RODS ON (B)(6) 2017. ON ORIGINAL SURGERY (B)(6) 2017 THE RODS WERE TORQUED DOWN IN CORRECT POSITION AT END OF CASE. PROCEDURE WAS COMPLETED AS PER THE TECHNIQUE GUIDE BUT WOULD LIKE THE TORQUE WRENCH TO BE EVALUATED TO MAKE SURE IT FUNCTIONED PROPERLY.
Patient problems: Injury; No Known Impact Or Consequence To Patient
MAUDE report 6671676 ↗InjuryJun 5, 2017Migration or Expulsion of Device
IT WAS REPORTED THAT THE CASE WAS DONE ON (B)(6) 2017. IT WAS FOUND OUT ON (B)(6) 2017 THAT THE ROD ON ONE SIDE OF A 2 LEVEL TLIF HAS MIGRATED OUT OF THE SCREWHEADS.
Patient problems: Injury; No Code Available
MAUDE report 6613254 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.