REFLEX HYBRIDRecalls & 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
- 112
- Deaths reported
- 0
- Injuries reported
- 25
- Recalls
- 0
We found 34 models of REFLEX HYBRID by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 112 adverse event reports in the FDA's MAUDE database, received between Feb 9, 2016 and Mar 23, 2023 — classified as 25 injuries, 87 malfunctions.
The most frequently reported specific device problem is “Fracture” (51 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
Most reported REFLEX HYBRID problems
Device problems
- Fracture51
- Break43
- Material Integrity Problem19
- Migration15
- Detachment Of Device Component14
- Material Deformation14
- Mechanical Problem10
- Detachment of Device or Device Component9
Patient problems
- No Known Impact Or Consequence To Patient57
- No Clinical Signs, Symptoms or Conditions32
- Injury15
- No Consequences Or Impact To Patient9
- No Code Available8
- No Information5
- Neck Pain4
- Ptosis4
REFLEX HYBRID models
34 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Reflex Hybrid 48511906BORTHOPEDIC MANUAL SURGICAL INSTRUMENT28 reports
- REFLEX HYBRID 48694014APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY9 reports
- REFLEX HYBRID 48651230APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY6 reports
- REFLEX HYBRID 48644014APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY5 reports
- REFLEX HYBRID 48511820BORTHOPEDIC MANUAL SURGICAL INSTRUMENT5 reports
- REFLEX HYBRID 48674014APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY4 reports
- REFLEX HYBRID 48511820ORTHOPEDIC MANUAL SURGICAL INSTRUMENT4 reports
- REFLEX HYBRID 48511905ORTHOPEDIC MANUAL SURGICAL INSTRUMENT4 reports
- REFLEX HYBRID 48511906ORTHOPEDIC MANUAL SURGICAL INSTRUMENT4 reports
- REFLEX HYBRID 48511905RORTHOPEDIC MANUAL SURGICAL INSTRUMENT4 reports
- REFLEX HYBRID 48651114APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY3 reports
- REFLEX HYBRID 48651116APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY3 reports
- REFLEX HYBRID 48651234APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY3 reports
- REFLEX HYBRID 48510420ORTHOPEDIC MANUAL SURGICAL INSTRUMENT3 reports
- REFLEX HYBRID 48651232APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- REFLEX HYBRID 48651237APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- REFLEX HYBRID 48651354APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- REFLEX HYBRID 48651472APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- REFLEX HYBRID 48694016APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- REFLEX HYBRID 48510800ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- REFLEX HYBRID 48510810ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- REFLEX HYBRID 48654014APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- REFLEX HYBRID 48674012APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- REFLEX HYBRID 48644016APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- REFLEX HYBRID 48651112APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- REFLEX HYBRID 48651118APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- REFLEX HYBRID 48651243APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- REFLEX HYBRID 48694012APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- REFLEX HYBRID 48510300ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- REFLEX HYBRID 48510100ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- REFLEX HYBRID 48510200ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- REFLEX HYBRID 48510614ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- REFLEX HYBRID 48511815ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- REFLEX HYBRID IS2081HYBORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
Recent REFLEX HYBRID adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMar 23, 2023Fracture; Migration; Fracture; Migration
A COMPANY REPRESENTATIVE REPORTED THAT APPROXIMATELY 7 YEARS POST-OPERATIVELY IT WAS NOTICED VIA X-RAY THAT A REFLEX-HYBRID VARIABLE ANGLE SELF TAP BONE SCREW HAD FRACTURED AND MIGRATED. THE PATIENT REPORTED PAIN.
Patient problems: Pain
MAUDE report 16598292 ↗InjuryOct 29, 2022Migration; Migration
IT WAS REPORTED THAT REFLEX VARIABLE, SELF-TAPPING SCREW HAD DEVIATED BEYOND THE PLATE POSTOPERATIVELY. THE PATIENT COMPLAINED OF THROAT DISCOMFORT. REVISION SURGERY HAS NOT BEEN PLANNED, PATIENT WILL WEAR A CERVICAL COLLAR FOR 6 MONTHS BEFORE CONSIDERATION OF ADDITIONAL TREATMENT.
Patient problems: Discomfort
MAUDE report 15696138 ↗MalfunctionJun 1, 2022Fracture; Fracture
A COMPANY REPRESENTATIVE REPORTED THAT A REFLEX-HYBRID SCREWDRIVER AND REFLEX-HYBRID FINAL TIGHTENING SCREWDRIVER BROKE DURING SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT CAPTURES THE REFLEX-HYBRID FINAL TIGHTENING SCREWDRIVER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14570135 ↗MalfunctionJun 1, 2022Fracture; Fracture
A COMPANY REPRESENTATIVE REPORTED THAT A REFLEX-HYBRID SCREWDRIVER AND REFLEX-HYBRID FINAL TIGHTENING SCREWDRIVER BROKE DURING SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT CAPTURES THE REFLEX-HYBRID SCREWDRIVER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14570095 ↗MalfunctionApr 11, 2022Fracture; Fracture
A COMPANY REPRESENTATIVE REPORTED THAT A REFLEX HYBRID SCREW EXTRACTOR INNER SHAFT FRACTURED DURING SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14078890 ↗MalfunctionMar 23, 2022Fracture; Fracture
IT WAS REPORTED THAT THE PIN OF A REFLEX HYBRID TEMPORARY FIXATION PIN BROKEN OFF OF THE INSTRUMENT DURING CLEANING OUTSIDE OF THE OR. THERE WAS NO ASSOCIATED PROCEDURE WITH THIS EVENT, THEREFORE, NO ADVERSE CONSEQUENCES TO ANY PATIENTS OR SURGICAL DELAYS WERE SEEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13869777 ↗MalfunctionMar 14, 2022Fracture; Fracture
A COMPANY REPRESENTATIVE REPORTED THAT THE TIP OF A REFLEX HYBRID REVISION DRIVER DRAW ROD SCREW EXTRACTOR FRACTURED WHEN REMOVING A SCREW FROM THE PLATE AND THE REFLEX HYBRID PLATE HOLDER IS,"COMING APART." THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT CAPTURES THE REFLEX HYBRID REVISION DRIVER DRAW ROD SCREW EXTRACTOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13763305 ↗MalfunctionMar 14, 2022Material Separation; Material Separation
A COMPANY REPRESENTATIVE REPORTED THAT THE TIP OF A REFLEX HYBRID REVISION DRIVER DRAW ROD SCREW EXTRACTOR FRACTURED WHEN REMOVING A SCREW FROM THE PLATE AND THE REFLEX HYBRID PLATE HOLDER IS, "COMING APART." THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT CAPTURES THE REFLEX HYBRID PLATE HOLDER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13763153 ↗MalfunctionFeb 22, 2022Material Deformation; Material Deformation
IT WAS REPORTED THAT A REFLEX-HYBRID FIXATION PIN AND SCREW EXTRACTOR INNER SHAFT WERE OBSERVED TO BE BENT OUTSIDE THE OR. THERE IS NO PROCEDURE ASSOCIATED WITH THIS REPORTED EVENT, NO PATIENT INVOLVEMENT, AND NO ADVERSE CONSEQUENCE HAS BEEN REPORTED. THIS REPORT WILL CAPTURE THE INNER SHAFT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13577967 ↗MalfunctionFeb 22, 2022Material Deformation; Material Deformation
IT WAS REPORTED THAT A REFLEX-HYBRID FIXATION PIN AND SCREW EXTRACTOR INNER SHAFT WERE OBSERVED TO BE BENT OUTSIDE THE OPERATING ROOM. THERE IS NO PROCEDURE ASSOCIATED WITH THIS REPORTED EVENT, NO PATIENT INVOLVEMENT, AND NO ADVERSE CONSEQUENCE HAS BEEN REPORTED. THIS REPORT WILL CAPTURE THE PIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13577966 ↗MalfunctionFeb 18, 2022Fracture; Fracture
IT WAS REPORTED THAT A REFLEX-HYBRID SCREWDRIVER "BROKE" INTRA-OPERATIVELY. SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13559997 ↗MalfunctionFeb 3, 2022Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING SCREW INSERTION, THE GOLD LOCKING RING OF A REFLEX HYBRID 1 LEVEL PLATE SEPARATED FROM THE PLATE. THE SCREW AND LOCKING RING WERE REMOVED AND A NEW SCREW WAS INSERTED. THE PLATE WAS LEFT IN THE PATIENT WITHOUT THE FOURTH LOCKING RING WHICH HAD SEPARATED FROM THE PLATE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT OR REPORTED SURGICAL DELAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13446824 ↗MalfunctionDec 23, 2021Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF A REFLEX HYBRID REVISION DRIVER DRAW ROD SCREW EXTRACTOR BROKE OFF INTRA-OPERATIVELY. SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13079127 ↗MalfunctionDec 22, 2021Fracture; Fracture
IT WAS REPORTED THAT A REFLEX HYBRID PLATE BENDER BROKE WHEN ATTEMPTING TO BEND THE PLATE. SURGERY WAS SUCCESSFULLY COMPLETED AND NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13061105 ↗MalfunctionNov 16, 2021Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF THE REFLEX HYBRID REVISION DRIVER DRAW ROD WAS OBSERVED TO BE BROKEN UPON INSPECTION. THERE WAS NO PROCEDURE ASSOCIATED WITH THIS EVENT. NO SURGICAL DELAY NOR ADVERSE CONSEQUENCES OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12819951 ↗
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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