AXSOSRecalls & reported problems across all models
Stryker GmbH · 184 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 505
- Deaths reported
- 0
- Injuries reported
- 214
- Recalls
- 0
We found 184 models of AXSOS by Stryker GmbH in the FDA's device registry (GUDID). Together they are named in 505 adverse event reports in the FDA's MAUDE database, received between Aug 18, 2015 and Sep 21, 2026 — classified as 214 injuries, 291 malfunctions.
The most frequently reported specific device problem is “Fracture” (240 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 AXSOS problems
Device problems
- Fracture240
- Break189
- Mechanical Jam37
- Adverse Event Without Identified Device or Use Problem28
- Appropriate Device Problem Term/Code Not Available21
- Material Deformation16
- Device Slipped15
- Positioning Failure15
Patient problems
- No Clinical Signs, Symptoms or Conditions113
- No Known Impact Or Consequence To Patient98
- Failure of Implant64
- Foreign Body In Patient60
- Insufficient Information38
- Implant Pain34
- Pain31
- Device Embedded In Tissue or Plaque30
AXSOS models
184 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- AXSOS 702753ORTHOPEDIC MANUAL SURGICAL INSTRUMENT57 reports
- AXSOS 705031SINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT30 reports
- AXSOS 705025INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT27 reports
- AXSOS 705004ORTHOPEDIC MANUAL SURGICAL INSTRUMENT24 reports
- AXSOS 703586INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT23 reports
- AXSOS 705031INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT8 reports
- AXSOS 705025SINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT8 reports
- AXSOS 705015ORTHOPEDIC MANUAL SURGICAL INSTRUMENT8 reports
- AXSOS 627644PLATE, FIXATION, BONE7 reports
- AXSOS 702747Plate, fixation, bone7 reports
- AXSOS 703585INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT6 reports
- AXSOS 627610SPLATE, FIXATION, BONE5 reports
- AXSOS 661024SPLATE, FIXATION, BONE5 reports
- AXSOS 703539ORTHOPEDIC MANUAL SURGICAL INSTRUMENT5 reports
- AXSOS 703540ORTHOPEDIC MANUAL SURGICAL INSTRUMENT5 reports
- AXSOS 702748ORTHOPEDIC MANUAL SURGICAL INSTRUMENT5 reports
- AXSOS 627640PLATE, FIXATION, BONE5 reports
- AXSOS 661040Plate, fixation, bone5 reports
- AXSOS 661134SPLATE, FIXATION, BONE4 reports
- AXSOS 661042SPLATE, FIXATION, BONE4 reports
- AXSOS 627642PLATE, FIXATION, BONE4 reports
- AXSOS 661046Plate, fixation, bone4 reports
- AXSOS 661430Plate, fixation, bone4 reports
- AXSOS 627648SPLATE, FIXATION, BONE4 reports
- AXSOS 661002SPlate, fixation, bone4 reports
- AXSOS 627616SPLATE, FIXATION, BONE3 reports
- AXSOS 627644SPLATE, FIXATION, BONE3 reports
- AXSOS 627646SPLATE, FIXATION, BONE3 reports
- AXSOS 703541INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT3 reports
- AXSOS 703542INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT3 reports
- AXSOS 661046SPLATE, FIXATION, BONE3 reports
- AXSOS 607330Screw, fixation, bone3 reports
- AXSOS 627608PLATE, FIXATION, BONE3 reports
- AXSOS 627614PLATE, FIXATION, BONE3 reports
- AXSOS 627646PLATE, FIXATION, BONE3 reports
- AXSOS 661028Plate, fixation, bone3 reports
- AXSOS 661424Plate, fixation, bone3 reports
- AXSOS 661436Plate, fixation, bone3 reports
- AXSOS 661440Plate, fixation, bone3 reports
- AXSOS 661448Plate, fixation, bone3 reports
- AXSOS 627488PLATE, FIXATION, BONE3 reports
- AXSOS 627204Plate, fixation, bone3 reports
- AXSOS 627233SPlate, fixation, bone3 reports
- AXSOS 705019-1ORTHOPEDIC MANUAL SURGICAL INSTRUMENT3 reports
- AXSOS 661030SPLATE, FIXATION, BONE2 reports
- AXSOS 661136SPLATE, FIXATION, BONE2 reports
- AXSOS 661428SPLATE, FIXATION, BONE2 reports
- AXSOS 661446SPLATE, FIXATION, BONE2 reports
- AXSOS 702760ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- AXSOS 703522Screw, fixation, bone2 reports
- AXSOS 703595ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- AXSOS 627618SPLATE, FIXATION, BONE2 reports
- AXSOS 702707ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- AXSOS 371528PLATE, FIXATION, BONE2 reports
- AXSOS 371536PLATE, FIXATION, BONE2 reports
- AXSOS 371548PLATE, FIXATION, BONE2 reports
- AXSOS 607370Screw, fixation, bone2 reports
- AXSOS 608070Screw, fixation, bone2 reports
- AXSOS 627610PLATE, FIXATION, BONE2 reports
- AXSOS 627612PLATE, FIXATION, BONE2 reports
- AXSOS 627616PLATE, FIXATION, BONE2 reports
- AXSOS 627638PLATE, FIXATION, BONE2 reports
- AXSOS 661026Plate, fixation, bone2 reports
- AXSOS 661030Plate, fixation, bone2 reports
- AXSOS 661038Plate, fixation, bone2 reports
- AXSOS 661044Plate, fixation, bone2 reports
- AXSOS 661050Plate, fixation, bone2 reports
- AXSOS 661070Plate, fixation, bone2 reports
- AXSOS 661150Plate, fixation, bone2 reports
- AXSOS 661160Plate, fixation, bone2 reports
- AXSOS 661175Plate, fixation, bone2 reports
- AXSOS 661426Plate, fixation, bone2 reports
- AXSOS 661428Plate, fixation, bone2 reports
- AXSOS 661432Plate, fixation, bone2 reports
- AXSOS 661434Plate, fixation, bone2 reports
- AXSOS 661455Plate, fixation, bone2 reports
- AXSOS 661738Plate, fixation, bone2 reports
- AXSOS 627456SPLATE, FIXATION, BONE2 reports
- AXSOS 705032INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT2 reports
- AXSOS 705022ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- AXSOS 705002INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT2 reports
- AXSOS 627203Plate, fixation, bone2 reports
- AXSOS 627233Plate, fixation, bone2 reports
- AXSOS 705020ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- AXSOS 627340SPLATE, FIXATION, BONE1 report
- AXSOS 627608SPLATE, FIXATION, BONE1 report
- AXSOS 627614SPLATE, FIXATION, BONE1 report
- AXSOS 627636SPLATE, FIXATION, BONE1 report
- AXSOS 627638SPLATE, FIXATION, BONE1 report
- AXSOS 627640SPLATE, FIXATION, BONE1 report
- AXSOS 661018SPLATE, FIXATION, BONE1 report
- AXSOS 661022SPLATE, FIXATION, BONE1 report
- AXSOS 661032SPLATE, FIXATION, BONE1 report
- AXSOS 661034SPLATE, FIXATION, BONE1 report
- AXSOS 661036SPLATE, FIXATION, BONE1 report
- AXSOS 661060SPLATE, FIXATION, BONE1 report
- AXSOS 661080SPLATE, FIXATION, BONE1 report
- AXSOS 661132SPLATE, FIXATION, BONE1 report
- AXSOS 661138SPLATE, FIXATION, BONE1 report
- AXSOS 661150SPLATE, FIXATION, BONE1 report
Recent AXSOS adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50841168 ↗MalfunctionSep 21, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50841166 ↗MalfunctionSep 21, 2026Fracture
The primary surgery was performed on (b)(6) 2024.The tip of the screwdriver broke while removing a locking screw. The plate and screw head were broken up using a carbide drill, and the remaining screw was extracted using the hospital¿s broken-screw extractor.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50840847 ↗InjuryAug 5, 2026Fracture
It was reported by the customer that the small end of the 2.5 mm Stryker Axsos drill bit broke while in use, leaving a fragment embedded in the patient's bone. The retained piece could not be removed. The surgeon is aware of the retained fragment. No patient harm was reported, no symptoms or adverse effects, and no additional treatment was required.
Patient problems: Foreign Body In Patient
MAUDE report 50146840 ↗MalfunctionAug 4, 2026Fracture
Patient problems: Insufficient Information
MAUDE report 50128713 ↗InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem
On (b)(6), the surgery for a proximal humeral fracture was performed using an AxSOS PH plate; however, one cortical screw and one locking screw in the distal region have become loose and are due to be removed on (b)(6). X-rays also suggest that the locking screw in the proximal region is becoming loose.
Patient problems: Insufficient Information
MAUDE report 50085785 ↗MalfunctionJul 9, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25764839 ↗InjuryJul 2, 2026Fracture
IT WAS REPORTED THAT THERE WAS A PLATE FAILURE THAT RESULTED IN A REVISION SURGERY.
Patient problems: Insufficient Information
MAUDE report 25689994 ↗InjuryJul 2, 2026Fracture
IT WAS REPORTED THAT THERE WAS A PLATE FAILURE THAT RE-FRACTURED AND WAS CONVERTED TO DFR.
Patient problems: Insufficient Information
MAUDE report 25689991 ↗InjuryJul 2, 2026Fracture
IT WAS REPORTED THAT THERE WAS A PLATE FAILURE THAT RESULTED IN A REVISION TO A NCB PLATE.
Patient problems: Insufficient Information
MAUDE report 25689989 ↗InjuryJul 2, 2026Fracture
IT WAS REPORTED THAT THERE WAS A PLATE FAILURE THAT RESULTED IN A REVISION SURGERY.
Patient problems: Insufficient Information
MAUDE report 25689986 ↗InjuryJul 2, 2026Fracture
IT WAS REPORTED THAT THERE WAS A PLATE FAILURE THAT RESULTED IN A REVISION SURGERY.
Patient problems: Insufficient Information
MAUDE report 25689984 ↗InjuryJul 2, 2026Fracture
IT WAS REPORTED THAT THERE WAS A PLATE FAILURE THAT RESULTED IN A REVISION SURGERY.
Patient problems: Insufficient Information
MAUDE report 25689798 ↗InjuryJul 2, 2026Fracture
IT WAS REPORTED THAT THERE WAS A PLATE FAILURE THAT RESULTED IN A REVISION SURGERY.
Patient problems: Insufficient Information
MAUDE report 25689641 ↗InjuryJul 2, 2026Fracture
IT WAS REPORTED THAT THERE WAS A PLATE FAILURE THAT RESULTED IN A REVISION SURGERY.
Patient problems: Insufficient Information
MAUDE report 25689617 ↗
Other Stryker GmbH products
All Stryker GmbH devices →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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