MANTISRecalls & reported problems across all models
Stryker Corporation · 14 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls
- 0
We found 14 models of MANTIS by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 22 adverse event reports in the FDA's MAUDE database, received between Mar 4, 2016 and Feb 4, 2025 — classified as 5 injuries, 17 malfunctions.
The most frequently reported specific device problem is “Fracture” (11 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 MANTIS problems
Device problems
- Fracture11
- Break9
- Material Integrity Problem5
- Mechanical Problem4
- Detachment Of Device Component3
- Loose or Intermittent Connection3
- Adverse Event Without Identified Device or Use Problem2
- Device Operates Differently Than Expected2
Patient problems
- No Known Impact Or Consequence To Patient18
- Injury4
- No Code Available2
- Foreign Body In Patient1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- No Information1
- Pain1
MANTIS models
14 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MANTIS 48480111ORTHOPEDIC MANUAL SURGICAL INSTRUMENT5 reports
- MANTIS 48281161ORTHOPEDIC MANUAL SURGICAL INSTRUMENT3 reports
- MANTIS 48285545Orthosis, spinal pedicle fixation, for degenerative disc disease2 reports
- MANTIS 48487100Orthosis, spondylolisthesis spinal fixation2 reports
- MANTIS 48285640Orthosis, spondylolisthesis spinal fixation1 report
- MANTIS 48285440ORTHOSIS, SPINAL PEDICLE FIXATION1 report
- MANTIS 48486080APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- MANTIS 48486090APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- MANTIS 48487090ORTHOSIS, SPINAL PEDICLE FIXATION1 report
- MANTIS 48487480ORTHOSIS, SPINAL PEDICLE FIXATION1 report
- MANTIS IS2511MANORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- MANTIS 48281167ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- MANTIS 48284080ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- MANTIS IS2619MANORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
Recent MANTIS adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryFeb 4, 2025Fracture; Fracture
IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY APPROXIMATELY FIVE YEARS POST-OPERATIVELY TO ADDRESS A FRACTURED XIA ROD.
Patient problems: Insufficient Information
MAUDE report 21309179 ↗InjuryDec 23, 2020Fracture; Fracture
IT WAS REPORTED THAT APPROXIMATELY 3 WEEKS FOLLOWING THE INITIAL SURGERY, AN ES2 INTEGRATED BLADE SCREW AND MANTIS STRAIGHT ROD FRACTURED POST-OPERATIVELY. REVISION SURGERY HAS BEEN PERFORMED. THIS RECORD REPRESENTS THE MANTIS STRAIGHT ROD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11069527 ↗MalfunctionJan 3, 2020Fracture; Fracture
IT WAS REPORTED THAT A XIA DEFORMITY REDUCTION LONG ARM MONOXIAL SCREW AND A MANTIS LONG CONSTRUCT HEX STRAIGHT ROD WAS FOUND FRACTURED DURING SCREW AND ROD REMOVAL POST-OPERATIVELY. THIS RECORD REPRESENTS THE ROD.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9547806 ↗MalfunctionNov 25, 2019Material Separation; Device Dislodged or Dislocated; Material Separation; Device Dislodged or Dislocated
IT WAS REPORTED THAT A MANTIS LONG CONSTRUCT 110 DEG ROD INSERTER METAL TIP DISENGAGED INTRA-OPERATIVELY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9372925 ↗InjurySep 27, 2019Migration or Expulsion of Device; Migration; Migration
A MANTIS ROD MIGRATED POST-OPERATIVELY. REVISION SURGERY WAS PERFORMED.
Patient problems: Injury; No Code Available
MAUDE report 9131615 ↗MalfunctionFeb 21, 2018Partial Blockage
IT IS REPORTED THAT DURING A HELICAL REMOVAL OF THE SCREW, THE SCREW HEAD GOT BLOCKED LATERALLY, CAUSING POTENTIAL CONSEQUENCES ON THE MUSCLE TISSUE. THE SCREW WAS REMOVED WITHOUT ADVERSE CONSEQUENCES FOR THE PATIENT, AND NO DELAY. PER EMAIL CORRESPONDENCE, THE REMOVAL SURGERY WAS DUE TO MEDICAL DECISION DUE TO PAIN. THERE IS NO INDICATION OF PRODUCT RELATED ISSUE WHICH RESULTED IN THE REPORTED PAIN OR THE REVISION SURGERY.
Patient problems: No Known Impact Or Consequence To Patient; Pain
MAUDE report 7285967 ↗MalfunctionFeb 20, 2018Fracture; Break; Fracture
IT WAS REPORTED THAT WHEN THE ROD WAS INSERTED WITH A ROD INSERTER FOR LUMBAR SPONDYLOLISTHESIS, THE ROD WAS BROKEN AT AROUND ROD HOLDER. HOWEVER, THE ROD WAS FIXED WITH BLOCKER AND THE OPERATION WAS FINISHED. NO ADVERSE CONSEQUENCES TO THE PATIENT IS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7284859 ↗MalfunctionJul 18, 2017Fracture; Difficult to Insert
IT WAS REPORTED THAT; TREATMENT FOR L2 FRACTURE. THE L1 LEFT VERTEBRAL BONE WAS HARD AND COULD NOT INSERT THE TAP COMPLETELY INTO L1. BUT INSERTED THE SCREW AND COMPLETE THE PROCEDURE. AFTER THAT IT WAS FOUND THE TIP OF TAP WAS FRACTURED AFTER PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6722985 ↗MalfunctionJun 19, 2017Adverse Event Without Identified Device or Use Problem; Device Operates Differently Than Expected; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT; SCREW LOST THE POLYAXIALITY. IN THE INTRAOPERATIVE MOMENT, THE RIGIDITY OF THE SCREW WAS IDENTIFIED.
Patient problems: Injury; No Known Impact Or Consequence To Patient
MAUDE report 6652076 ↗InjuryJun 19, 2017Break; Mechanical Problem; Break; Mechanical Problem; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT; SCREW LOST THE POLYAXIALITY. IN THE INTRAOPERATIVE MOMENT, THE RIGIDITY OF THE SCREW WAS IDENTIFIED.
Patient problems: Injury; No Known Impact Or Consequence To Patient
MAUDE report 6652074 ↗MalfunctionApr 17, 2017Detachment Of Device Component; Loose or Intermittent Connection; Mechanical Problem; Device Inoperable; Detachment Of Device Component; Mechanical Problem
IT WAS REPORTED THAT DURING MEDICAL PROCEDURE THE ROD INSERTER WAS WITHOUT FUNCTION. THE DISTAL END OF THE ITEM LOOSENED FROM THE RESIDUE OF THE INSTRUMENT. A PROPER FIXATION OF THE ROD WAS NOT POSSIBLE ANYMORE. REPLACEMENT WAS AVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6498965 ↗MalfunctionApr 13, 2017Detachment Of Device Component; Loose or Intermittent Connection; Mechanical Problem; Device Operates Differently Than Expected; Detachment Of Device Component; Mechanical Problem
IT WAS REPORTED THAT DURING MEDICAL PROCEDURE THE ROD INSERTER WAS WITHOUT FUNCTION. THE DISTAL END OF THE ITEM LOOSENED FROM THE RESIDUE OF THE INSTRUMENT. A PROPER FIXATION OF THE ROD WAS NOT POSSIBLE ANYMORE. REPLACEMENT WAS AVAILABLE
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6490353 ↗MalfunctionJan 27, 2017Break; Fracture; Material Integrity Problem; Fracture; Material Integrity Problem
IT WAS REPORTED THAT AN ITEM BROKE DURING MEDICAL PROCEDURE. REPLACEMENT WAS AVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6282604 ↗InjuryOct 27, 2016Material Erosion; Difficult to Remove
IT WAS REPORTED THAT; WHEN TRYING TO REMOVE THE INSERTER FROM THE ALREADY FINAL FIXED IMPLANTATION CONSTRUCT, THE LOWER PART OF THE INSERTER DISSOLVED. THE CUT WAS EXTENDED BY 1CM AND THE INSTRUMENT COULD BE REMOVED COMPLETELY. REPLACEMENT WAS AVAILABLE AND THE PROCEDURE COULD BE COMPLETED SUCCESSFULLY. SALES REP WAS PRESENT DURING SURGERY.
Patient problems: No Information
MAUDE report 6060460 ↗MalfunctionSep 30, 2016Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem
IT WAS REPORTED THAT A SMALL CIRCULAR PIECE OF METAL WAS NOTICED IN THE VERTEBRAL BODY DURING AN INTEROP FILM. IT WAS DETERMINED UPON EXAMINATION THAT THE METAL PIECE MAY HAVE BROKEN OFF THE DISTAL END OF A JAM SHIDI.
Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient
MAUDE report 5990290 ↗
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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