Fortex Pedicle Screw SystemRecalls & reported problems across all models
Xtant Medical Holdings, Inc. · 14 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 39
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 0
We found 14 models of Fortex Pedicle Screw System by Xtant Medical Holdings, Inc. in the FDA's device registry (GUDID). Together they are named in 39 adverse event reports in the FDA's MAUDE database, received between Mar 26, 2018 and Apr 24, 2026 — classified as 4 injuries, 35 malfunctions.
The most frequently reported specific device problem is “Fracture” (15 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 Fortex Pedicle Screw System problems
Device problems
- Fracture15
- Material Fragmentation13
- Material Twisted/Bent5
- Patient Device Interaction Problem4
- Break3
- Insufficient Device Problem Information1
- Loss of or Failure to Bond1
- Solder Joint Fracture1
Patient problems
- No Known Impact Or Consequence To Patient18
- No Clinical Signs, Symptoms or Conditions13
- No Consequences Or Impact To Patient4
- Pain4
Fortex Pedicle Screw System models
14 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Fortex Pedicle Screw System X022-0240Orthosis, spinal pedicle fixation15 reports
- Fortex Pedicle Screw System X070-0040Orthosis, spondylolisthesis spinal fixation5 reports
- Fortex Pedicle Screw System X022-0161Orthosis, spondylolisthesis spinal fixation3 reports
- Fortex Pedicle Screw System N60001073Orthosis, spondylolisthesis spinal fixation2 reports
- Fortex Pedicle Screw System X010-0151Orthosis, spinal pedicle fixation2 reports
- Fortex Pedicle Screw System X022-0042Orthosis, spondylolisthesis spinal fixation2 reports
- Fortex Pedicle Screw System X022-0096Orthosis, spondylolisthesis spinal fixation2 reports
- Fortex Pedicle Screw System X070-0011Orthosis, spondylolisthesis spinal fixation2 reports
- Fortex Pedicle Screw System N60000463Orthosis, spinal pedicle fixation1 report
- Fortex Pedicle Screw System N60000470Orthosis, spinal pedicle fixation1 report
- Fortex Pedicle Screw System N60000485Orthosis, spinal pedicle fixation1 report
- Fortex Pedicle Screw System X010-0167Orthosis, spinal pedicle fixation1 report
- Fortex Pedicle Screw System X022-0095Orthosis, spondylolisthesis spinal fixation1 report
- Fortex Pedicle Screw System X070-0045Orthosis, spinal pedicle fixation1 report
Recent Fortex Pedicle Screw System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionApr 24, 2026Fracture
THE MANUFACTURER WAS MADE AWARE OF AN INSTRUMENT MALFUNCTION ON (B)(6) 2026. IT WAS REPORTED THAT THE DISTAL THREADING OF A PEDICLE SCREWDRIVER ASSEMBLY WAS DAMAGED, WHICH RESULTED IN A SYSTEM SCREW BEING STUCK ON THE DRIVER. THERE WERE NO KNOWN PATIENT COMPLICATIONS OR DELAYS IN TREATMENT ASSOCIATED WITH THIS COMPLAINT. AN ALTERNATIVE AVAILABLE INSTRUMENT WAS USED TO SUCCESSFULLY COMPLETE THE SURGICAL PROCEDURE. A REPLACEMENT INSTRUMENT WAS PROVIDED, AND AN RMA# WAS ISSUED FOR RETURN OF THE COMPLAINT INSTRUMENT, WHICH WAS RECEIVED AT THE MANUFACTURER FOR ASSESSMENT ON (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24984024 ↗MalfunctionJul 22, 2024Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT UNDERWENT A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) PROCEDURE AT A LEVEL ADJACENT TO AN EXISTING POSTERIOR FIXATION CONSTRUCT. DURING THE REMOVAL OF A CROSS LINK, IT WAS NOTED THAT THE DISTAL TIP OF THE CROSS LINK DRIVER FRACTURED OFF. NO PIECES WERE RETAINED BY THE PATIENT. A SPARE DRIVER WAS USED TO FINISH THE REMAINDER OF THE SURGERY. NO PATIENT COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19801357 ↗MalfunctionDec 27, 2023Break; Break
THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON 11/28/2023. IT WAS REPORTED THAT A SYSTEM 5.5MM CANNULATED TAP MALFUNCTIONED WHILE BEING USED IN A SURGICAL PROCEDURE. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT, AN ALTERNATE AVAILABLE INSTRUMENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. AN RMA# WAS ISSUED FOR RETURN OF THE COMPLAINT INSTRUMENT, WHICH WAS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR ASSESSMENT DUE TO BEING DISCARDED AT THE SURGICAL FACILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18404973 ↗MalfunctionSep 14, 2023Break; Break
THE MANUFACTURER WAS MADE AWARE OF PRODUCT COMPLAINTS ON (B)(6) 2023. IT WAS REPORTED THAT A SYSTEM PEDICLE SCREWDRIVER AND TORQUE HANDLE WERE IDENTIFIED AS BROKEN AND REQUESTED TO BE REPLACED. THE COMPLAINANT STATED THAT THEY WERE INFORMED, "THE DRIVER JUST FELL APART AFTER IT WAS NOT WORKING PROPERLY THEN THE TOP CAME APART.", AND THE "TORQUE HANDLE HAD A DRIVER STUCK IN IT AND AS I WAS PULLING IT APART IT BROKE." THERE WERE NO KNOWN PATIENT COMPLICATIONS OR DELAY IN TREATMENT ASSOCIATED WITH THIS COMPLAINT. ALTERNATE AVAILABLE INSTRUMENTS WERE USED TO SUCCESSFULLY COMPLETE THE SURGICAL PROCEDURE. A RETURN AUTHORIZATION WAS ISSUED FOR RETURN OF THE COMPLAINT INSTRUMENTS, WHICH AS OF (B)(6) 2023 HAVE NOT BEEN RECEIVED AT THE MANUFACTURER FOR COMPLAINT ASSESSMENT. ADDITIONAL ATTEMPTS TO GATHER RELEVANT COMPLAINT INCIDENT INFORMATION AND CONFIRM RETURN OF THE COMPLAINT INSTRUMENTS WERE UNSUCCESSFUL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17750291 ↗MalfunctionJun 8, 2022Material Fragmentation; Material Fragmentation
THE MANUFACTURER RECEIVED NOTIFICATION OF A SYSTEM INSTRUMENT MALFUNCTION ON (B)(6) 2022. IT WAS REPORTED THAT THE DISTAL TIP OF A SYSTEM SCREWDRIVER FRACTURED WHILE ATTEMPTING TO REMOVE A SYSTEM SCREW FROM AN ALTERNATE MANUFACTURER. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. THE COMPLAINT SCREWDRIVER WAS RECEIVED ON 6/03/2022 AT THE MANUFACTURER FOR COMPLAINT ASSESSMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14639066 ↗MalfunctionApr 19, 2022Material Fragmentation; Material Fragmentation
THE MANUFACTURER RECEIVED NOTIFICATION OF A SYSTEM SCREWDRIVER MALFUNCTION ON 3/22/2022. IT WAS REPORTED THAT THE SYSTEM SCREWDRIVER WAS NOT IN FUNCTIONAL CONDITION DUE TO WORN THREADING AND WAS REQUESTED TO BE REPLACED. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. AN ALTERNATE DRIVER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE COMPLAINT SCREWDRIVER WAS RECEIVED ON 3/30/2022 AT THE MANUFACTURER FOR COMPLAINT ASSESSMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14148603 ↗MalfunctionDec 13, 2021Material Fragmentation; Material Fragmentation
THE MANUFACTURER RECEIVED NOTIFICATION OF A SYSTEM SCREWDRIVER MALFUNCTION ON 11/18/2021. IT WAS REPORTED THAT THE DISTAL THREADS OF A SYSTEM SCREWDRIVER FRACTURED WHILE BEING USED IN A SURGICAL PROCEDURE. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. AN ALTERNATE DRIVER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE COMPLAINT SCREWDRIVER WAS RECEIVED ON 11/24/2021 AT THE MANUFACTURER FOR COMPLAINT ASSESSMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12984798 ↗MalfunctionJun 23, 2021Fracture; Fracture
THE COMPANY RECEIVED COMMUNICATION ON (B)(6) 2021 FOR A SYSTEM SCREWDRIVER THAT WAS REPORTED TO NOT FUNCTION AS INTENDED DUE TO HAVING A WORN SQUARE THREAD DETAIL AND WAS REQUESTED TO BE REPLACED. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. AN ALTERNATE AVAILABLE INSTRUMENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. A RETURN AUTHORIZATION NUMBER WAS ISSUED FOR RETURN OF THE COMPLAINT INSTRUMENT, WHICH ARRIVED AT THE COMPANY FOR COMPLAINT ASSESSMENT ON 6/04/2021.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12050414 ↗MalfunctionMar 10, 2021Material Fragmentation; Material Fragmentation
THE COMPANY RECEIVED COMMUNICATION ON (B)(6) 2021 THAT THE DISTAL TIP OF A SYSTEM DRIVER FRACTURED WHEN TIGHTENING A SYSTEM SCREW DURING A L4-L5 PLIF PROCEDURE. THE FRACTURED PORTION OF THE DRIVER WAS IMMEDIATELY REMOVED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO KNOWN PATIENT COMPLICATIONS OR DELAY IN TREATMENT ASSOCIATED WITH THIS COMPLAINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11457576 ↗MalfunctionNov 6, 2020Material Twisted/Bent; Material Twisted/Bent
THE COMPANY RECEIVED NOTIFICATION ON 10/09/2020 FROM A FOREIGN DISTRIBUTOR THAT REPORTED A PRODUCT COMPLAINT THAT OCCURRED DURING A SURGICAL PROCEDURE ON (B)(6) 2020. IT WAS REPORTED THAT TWO SYSTEM FINAL LOCKING CAPS WOULD NOT LOCK INTO THE THREADING OF TWO SYSTEM PEDICLE SCREW. THE COMPLAINANT STATED THAT, "IT APPEARS THAT THE THREAD ON THE SCREW HEAD AND/OR LOCKING CAP IS DAMAGED/FAULTY." THERE WERE NO KNOWN PATIENT COMPLICATIONS OR DELAY IN TREATMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED, THE COMPLAINT PEDICLE SCREW AND CAPS WERE REMOVED AND REPLACED WITHOUT INCIDENT. THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS SUBMISSION: 3005031160-2020-00025, 3005031160-2020-00029, 3005031160-2020-00031.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10802935 ↗MalfunctionNov 6, 2020Material Twisted/Bent; Material Twisted/Bent
THE COMPANY RECEIVED NOTIFICATION ON 10/09/2020 FROM A FOREIGN DISTRIBUTOR THAT REPORTED A PRODUCT COMPLAINT THAT OCCURRED DURING A SURGICAL PROCEDURE ON (B)(6) 2020. IT WAS REPORTED THAT TWO SYSTEM FINAL LOCKING CAPS WOULD NOT LOCK INTO THE THREADING OF TWO SYSTEM PEDICLE SCREW. THE COMPLAINANT STATED THAT, "IT APPEARS THAT THE THREAD ON THE SCREW HEAD AND/OR LOCKING CAP IS DAMAGED/FAULTY." THERE WERE NO KNOWN PATIENT COMPLICATIONS OR DELAY IN TREATMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED, THE COMPLAINT PEDICLE SCREW AND CAPS WERE REMOVED AND REPLACED WITHOUT INCIDENT. THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS SUBMISSION: 3005031160-2020-00025, 3005031160-2020-00029, 3005031160-2020-00030.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10802911 ↗MalfunctionNov 6, 2020Material Twisted/Bent; Material Twisted/Bent
THE COMPANY RECEIVED NOTIFICATION ON 10/09/2020 FROM A FOREIGN DISTRIBUTOR THAT REPORTED A PRODUCT COMPLAINT THAT OCCURRED DURING A SURGICAL PROCEDURE ON (B)(6) 2020. IT WAS REPORTED THAT TWO SYSTEM FINAL LOCKING CAPS WOULD NOT LOCK INTO THE THREADING OF TWO SYSTEM PEDICLE SCREW. THE COMPLAINANT STATED THAT, "IT APPEARS THAT THE THREAD ON THE SCREW HEAD AND/OR LOCKING CAP IS DAMAGED/FAULTY." THERE WERE NO KNOWN PATIENT COMPLICATIONS OR DELAY IN TREATMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED, THE COMPLAINT PEDICLE SCREW AND CAPS WERE REMOVED AND REPLACED WITHOUT INCIDENT. THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS SUBMISSION: 3005031160-2020-00025, 3005031160-2020-00030, 3005031160-2020-00031.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10802883 ↗MalfunctionNov 6, 2020Material Twisted/Bent; Material Twisted/Bent
THE COMPANY RECEIVED NOTIFICATION ON 10/09/2020 FROM A FOREIGN DISTRIBUTOR THAT REPORTED A PRODUCT COMPLAINT THAT OCCURRED DURING A SURGICAL PROCEDURE ON (B)(6) 2020. IT WAS REPORTED THAT TWO SYSTEM FINAL LOCKING CAPS WOULD NOT LOCK INTO THE THREADING OF TWO SYSTEM PEDICLE SCREW. THE COMPLAINANT STATED THAT, "IT APPEARS THAT THE THREAD ON THE SCREW HEAD AND/OR LOCKING CAP IS DAMAGED/FAULTY." THERE WERE NO KNOWN PATIENT COMPLICATIONS OR DELAY IN TREATMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED, THE COMPLAINT PEDICLE SCREW AND CAPS WERE REMOVED AND REPLACED WITHOUT INCIDENT. THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS SUBMISSION: 3005031160-2020-00029, 3005031160-2020-00030, 3005031160-2020-00031.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10802876 ↗MalfunctionAug 28, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
THE COMPANY RECEIVED NOTIFICATION ON (B)(6) 2020 FROM A FOREIGN DISTRIBUTOR REGARDING A PRODUCT COMPLAINT FROM A SURGICAL PROCEDURE PERFORMED ON (B)(6) 2020. THE COMPLAINANT REPORTED THAT THE THREADING ON A PEDICLE SCREW AND PEDICLE SCREW CAP WERE STRIPPED WHEN FINAL TIGHTENING THE CAP AFTER ROD INTRODUCTION WAS PERFORMED. THE COMPLAINT PEDICLE SCREW AND CAP WERE REMOVED AND REPLACED WITH ALTERNATE DEVICES WITH NO FURTHER ISSUES. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS PRODUCT COMPLAINT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10466059 ↗MalfunctionFeb 7, 2020Material Fragmentation; Material Fragmentation
THE COMPLAINANT REPORTED THAT DURING A LUMBAR ARTHRODESIS PROCEDURE ON (B)(6) 2020, THE DISTAL TIP OF A FINAL LOCKING CAP DRIVER WAS BROKEN. THERE WERE NO REPORTED PATIENT COMPLICATIONS ASSOCIATED WITH THIS INSTRUMENT MALFUNCTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9683945 ↗
Other Xtant Medical Holdings, Inc. products
All Xtant Medical Holdings, Inc. 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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