RELIANCERecalls & reported problems across all models
Stryker Corporation · 9 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 0
We found 9 models of RELIANCE by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 21 adverse event reports in the FDA's MAUDE database, received between Apr 27, 2016 and Oct 20, 2022 — classified as 1 injury, 20 malfunctions.
The most frequently reported specific device problem is “Break” (16 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 RELIANCE problems
Device problems
- Break16
- Material Integrity Problem10
- Fracture9
- Material Deformation5
- Bent2
- Crack2
- Detachment Of Device Component2
- Device Operates Differently Than Expected2
Patient problems
- No Known Impact Or Consequence To Patient19
- No Consequences Or Impact To Patient3
- Bone Fracture(s)1
- No Clinical Signs, Symptoms or Conditions1
- No Information1
RELIANCE models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- RELIANCE IS3048RELORTHOPEDIC MANUAL SURGICAL INSTRUMENT5 reports
- RELIANCE 48360200ORTHOPEDIC MANUAL SURGICAL INSTRUMENT4 reports
- RELIANCE 48361220ORTHOPEDIC MANUAL SURGICAL INSTRUMENT4 reports
- RELIANCE 48360100ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- RELIANCE 48361630ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- RELIANCE 48360134ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- RELIANCE 48360310ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- RELIANCE 48360210ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- RELIANCE 48361150ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
Recent RELIANCE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionOct 20, 2022Material Deformation; Material Deformation
A COMPANY REPRESENTATIVE REPORTED THAT THE INNER SHAFT OF A RELIANCE AL INTEGRATED DISTRACTOR INSERTER DEFORMED AND JAMMED DURING USE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A FIVE-MINUTE SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15642378 ↗MalfunctionNov 12, 2018Material Deformation; Break; Material Deformation
IT WAS REPORTED THAT THE DEVICE CHIPPED INTRA-OP. NO ADVERSE CONSEQUENCE TO THE PATIENT WAS REPORTED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8061339 ↗MalfunctionMay 2, 2018Fracture; Break; Detachment Of Device Component; Fracture
IT WAS REPORTED THAT WHILE THE SURGEON WAS PREPPING THE DISC SPACE TO PLACE AN INTER-BODY CAGE, THE 7MM AND 8MM CUSTOM OVAL SHAVERS BROKE IN THE PATIENT. A BACKUP SHAVER WAS USED TO COMPLETE THE PROCEDURE. FRAGMENTS WERE RETRIEVED SUCCESSFULLY. THERE ARE NO REPORTS OF ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7479032 ↗MalfunctionMay 2, 2018Fracture; Break; Detachment Of Device Component; Fracture
IT WAS REPORTED THAT WHILE THE SURGEON WAS PREPPING THE DISC SPACE TO PLACE AN INTER-BODY CAGE, THE 7MM AND 8MM CUSTOM OVAL SHAVERS BROKE IN THE PATIENT. A BACKUP SHAVER WAS USED TO COMPLETE THE PROCEDURE. FRAGMENTS WERE RETRIEVED SUCCESSFULLY. THERE ARE NO REPORTS OF ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7478960 ↗MalfunctionJan 10, 2018Bent; Break; Component Falling; Material Separation; Bent
IT WAS REPORTED THAT; DURING AN ALIF, THE DISTRACTOR WAS HANDED TO THE SURGEON. DURING THE INSTRUMENT HANDOFF, THE SURGEON NOTICED THERE WAS NO TENSION ON THE HANDLE OF THE INSTRUMENT. HE LOOKED DOWN AND NOTICED THE HANDLE HAD SEPARATED FROM THE BODY OF THE INSTRUMENT AND THE CORRESPONDING SCREW AND SPRING FELL OUT OF THE HANDLE. AT THE TIME NO ONE WAS INJURED AND LUCKILY WE HAD A SECOND DISTRACTOR AS BACKUP SO WE QUICKLY SWITCHED TO THE BACK UP DISTRACTOR... CASE WAS THEN PERFORMED FLAWLESSLY WITH NO ISSUES. IT WAS APPARENT THAT THE SMALL PIN AT THE JOINTED PORTION OF THE DISTRACTOR HAD BROKEN ALONG WITH THE SPRING, WHICH CAUSED THE ISSUE. THIS MUST HAVE HAPPENED DURING STERILIZATION BECAUSE IT WAS NOT NOTICED DURING CASE PREP OR WHEN THE INSTRUMENTS WERE HANDED OFF TO SPD.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7180823 ↗MalfunctionSep 15, 2017Material Deformation
IT WAS REPORTED THAT; SURGEON USED CHISEL TO CUT THE FACET JOINT! THE CUTTING EDGE CAME OUT DEFORMED. THE FACET JOINT WAS CUT AND TAKEN OUT WITH ANOTHER CHISEL THAT THE HOSPITAL OWNED. NO DEFORMITY OF THE SECOND CHISEL.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 6870020 ↗MalfunctionMay 12, 2017Break; Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE DOCTOR WAS PREPPING THE DISC SPACE WITH THE 7MM OVAL SHAVER, SHAVER BROKE IN THE DISC. FRAGMENT WAS RETRIEVED WITHOUT ADVERSE CONSEQUENCES. THE NEXT SIZE UP SHAVER WAS USED.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 6565077 ↗MalfunctionApr 25, 2017Mechanical Problem; Device Operates Differently Than Expected; Mechanical Problem
IT WAS REPORTED THAT; WHEN THREADING THE T HANDLE IS ALMOST COMPLETELY DOWN. THE THREADS WERE JUMPING THEREFORE NOT ADVANCING THE IMPLANT. I WASN'T ADVANCING WHILE INSERTING THE IMPLANT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6518664 ↗MalfunctionApr 12, 2017Crack; Fracture; Material Integrity Problem; Crack; Material Integrity Problem
IT WAS REPORTED THAT DURING LUMBAR FUSION SURGERY,THE BOTTOM OF THE PITUITARY RONGEUR IS FRACTURED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6485381 ↗MalfunctionMar 28, 2017Break; Fracture; Material Integrity Problem; Fracture; Material Integrity Problem
IT WAS REPORTED THAT THE PITUITARY WAS BEING USED WHEN THE BACK TRIGGER PIECE BROKE WHEN THE SURGEON WENT TO SQUEEZE THE INSTRUMENTS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6440686 ↗MalfunctionJan 16, 2017Break; Fracture; Fracture
IT WAS REPORTED THAT; PITUITARY BROKE WHILE USING DURING TLIF.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6254357 ↗MalfunctionJan 3, 2017Material Integrity Problem; Bent; Break; Material Integrity Problem
IT WAS REPORTED THAT; NERVE ROOT RETRACTOR BROKE WHEN BENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6219892 ↗MalfunctionNov 14, 2016Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem
IT WAS REPORTED THAT THE OSTEOTOMY STRAIGHT CHISEL BOWED AT THE END AND BROKE PARTIALLY. UPDATE: PER EMAIL CORRESPONDENCE ATTACHED, "NO ADDITIONAL SURGERY, SURGEON WAS ABLE TO RETRIEVE THE BROKEN PIECE WITH TWEEZERS."
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6099405 ↗MalfunctionOct 3, 2016Material Deformation; Material Integrity Problem; Break; Material Deformation; Material Integrity Problem
IT WAS REPORTED THAT: INSTRUMENT BROKE DURING THE LUMBAR ARTHRODESIS PROCEDURE. THE SURGEON USED ANOTHER INSTRUMENT THAT WAS IN THE BOX.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5994936 ↗MalfunctionSep 30, 2016Fracture; Material Integrity Problem; Break; Crack; Fracture; Material Integrity Problem
IT WAS REPORTED THAT; DURING SURGERY A TEAR DROP CURETTE WAS BROKEN. AT THE BOTTOM OF THE TEARDROP, THE INSTRUMENT HAS BEEN CRACKED APART.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5991979 ↗
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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