EXPEDIUM VERSE 199723650Recalls & reported problems
Medos International Sàrl · EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 6.0 x 50mm · Class 2 · Implant
All models of EXPEDIUM VERSE (90)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This is a DePuy Synthes Expedium Verse fenestrated cortical screw, a pedicle screw used to fix the spine during fusion surgery. The 27 reports mostly describe the screw breaking after implantation, in some cases leaving a fragment in the patient, plus screws loosening or slipping and implant failure that led to repeat surgery to remove hardware. Reports mention 21 injuries, no deaths, and 6 malfunctions. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 27
- Deaths reported
- 0
- Injuries reported
- 21
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10705034403076), received between Oct 30, 2017 and Apr 6, 2026 — classified as 21 injuries, 6 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break16
- Loose or Intermittent Connection5
- Adverse Event Without Identified Device or Use Problem4
- Entrapment of Device2
- Device Slipped1
- Device-Device Incompatibility1
Patient problems
- Failure of Implant13
- No Clinical Signs, Symptoms or Conditions6
- Foreign Body In Patient2
- Nerve Damage2
- No Code Available2
- Spinal Column Injury2
- Unspecified Tissue Injury2
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 6, 2026Break
THE SCREW WAS IMPLANTED IN THE PATIENT AND THE SCREW BROKE AT TWO DIFFERENT PARTS. THE SURGEON REMOVED THE SCREW ON (B)(6) 2026. A PART OF THE SCREW REMAINED IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24793678 ↗InjurySep 3, 2024Break; Entrapment of Device; Break; Entrapment of Device
IT WAS REPORTED THAT ON (B)(6) 2024 A REMOVAL OF BROKEN SCREW HEADS AT L3 WAS PERFORMED. THE ORIGINAL CONSTRUCT WAS A SPINAL FUSION AT L1-L3 FOR A FRACTURE AT L2. THE ORIGINAL SURGERY DATE WAS (B)(6) 2023. ALL IMPLANTS WERE REMOVED ON (B)(6) 2024. X-RAY WAS PERFORMED, AND THE PATIENT REQUIRED REVISION AND REMOVAL OF IMPLANTS. THIS REPORT INVOLVES ONE EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 6.0 X 50MM THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: Foreign Body In Patient
MAUDE report 20130277 ↗InjurySep 3, 2024Break; Entrapment of Device; Break; Entrapment of Device
IT WAS REPORTED THAT ON (B)(6) 2024 A REMOVAL OF BROKEN SCREW HEADS AT L3 WAS PERFORMED. THE ORIGINAL CONSTRUCT WAS A SPINAL FUSION AT L1-L3 FOR A FRACTURE AT L2. THE ORIGINAL SURGERY DATE WAS (B)(6) 2023. ALL IMPLANTS WERE REMOVED ON (B)(6) 2024. X-RAY WAS PERFORMED, AND THE PATIENT REQUIRED REVISION AND REMOVAL OF IMPLANTS. THIS REPORT INVOLVES ONE EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 6.0 X 50MM. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: Foreign Body In Patient
MAUDE report 20130123 ↗MalfunctionJun 20, 2024Break; Break
IT WAS REPORTED THAT ON (B)(6) 2024, DURING A CASE THAT USED A VERSE SCREW 6.0 X 50, A THIN WIRE WAS FOUND COMING OUT OF SCREW WHILE INPUTTING INTO PATIENT'S BODY. THE SCREW AND FRAGMENT WERE IMMEDIATELY REMOVED FROM PATIENT. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO NEGATIVE OUTCOME TO THE PATIENT THIS REPORT INVOLVES ONE (1) EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 6.0 X 50MM. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19574351 ↗InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A DATABASE RELATED RESEARCH ACTIVITY (DRRA): SPINE TANGO SOA REPORT - TLIF THE FOLLOWING COMPLICATIONS HAVE BEEN IDENTIFIED: NEUROCOMPRESSION. COMPLICATION TIME/INTERVENTION. REPEAT SURGERY. THIS REPORT INVOLVES ONE EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 6.0 X 50MM. THIS IS REPORT 4 OF 6 FOR PC-(B)(4).
Patient problems: Nerve Damage
MAUDE report 18462960 ↗InjuryJan 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A DATABASE RELATED RESEARCH ACTIVITY (DRRA): SPINE TANGO SOA REPORT - TLIF. THE FOLLOWING COMPLICATIONS HAVE BEEN IDENTIFIED: HARDWARE REMOVAL, COMPLICATION TIME/INTERVENTION, REPEAT SURGERY. THIS IS FOR DEPUY SYNTHES SPINE EXPEDIUM VERSE FENESTRATED PRODUCTS. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).
Patient problems: Insufficient Information
MAUDE report 18451376 ↗InjuryJan 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A DATABASE RELATED RESEARCH ACTIVITY (DRRA): SPINE TANGO SOA REPORT - TLIF. THE FOLLOWING COMPLICATIONS HAVE BEEN IDENTIFIED: NEUROCOMPRESSION, NON-UNION. COMPLICATION TIME/INTERVENTION. REPEAT SURGERY. THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE FEN SCR 6.0X50. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).
Patient problems: Nerve Damage; Nonunion/Delayed-union Bone Fracture
MAUDE report 18447536 ↗InjuryJan 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A DATABASE RELATED RESEARCH ACTIVITY (DRRA): SPINE TANGO SOA REPORT - TLIF THE FOLLOWING COMPLICATIONS HAVE BEEN IDENTIFIED: ADJACENT SEGMENT PATHOLOGY. COMPLICATION TIME/INTERVENTION: REPEAT SURGERY. THIS IS FOR DEPUY SYNTHES SPINE EXPEDIUM VERSE FENESTRATED PRODUCTS (5.5 EXP VERSE FEN SCR 6.0X50 FOR (B)(4).
Patient problems: Osteolysis
MAUDE report 18445955 ↗InjuryOct 7, 2022Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT DATE OF IMPLANT: (B)(6) 2022, (B)(6) HOSPITAL. BROKEN SCREW IN L1 (6X50MM). THERE IS A FRACTURE BETWEEN T11 & T12 ON THE X-RAY IN ADDITION TO THE BROKEN SCREWS. SURGEON REMOVING WHOLE CONSTRUCT AND REPLACING WITH LIFE HEALTHCARE SCREWS. PATIENT STATUS/ OUTCOME / CONSEQUENCES: YES. REVISION TO REMOVE BROKEN SCREW AND EXTEND CONSTRUCT. THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE FEN SCR 6.0X50. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: Failure of Implant; Unspecified Tissue Injury
MAUDE report 15561666 ↗InjurySep 30, 2022Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT HAD SURGERY DURING WHICH THE SCREW WAS IMPLANTED ON (B)(6) 2022. ON (B)(6) 2022, THE PATIENT HAD A REVISION SURGERY BECAUSE THE SCREW WAS BROKEN. THE SURGEON REMOVED THE WHOLE CONSTRUCT TO REPLACE SCREWS AND EXTEND THE CONSTRUCT. THIS REPORT INVOLVES ONE EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 6.0 X 50MM. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: Failure of Implant; Unspecified Tissue Injury
MAUDE report 15509178 ↗InjurySep 22, 2022Break; Break
DEVICE REPORT FROM SWITZERLAND REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT HAD BEEN TREATED FOR AN UNSTABLE TH 12 FRACTURE WITH EXPEDIUM VERSE AT THE HEIGHTS OF TH11-LKW 2 WITH CEMENTED SCREWS. THE OPERATION WAS COMPLETED WITHOUT DIFFICULTY OR COMPLICATIONS. DURING A POSTOPERATIVE FOLLOW-UP CHECK, IT WAS FOUND THAT BOTH SCREWS IN LKW1 WERE BROKEN NEAR THE HEAD. AS A RESULT, A REVISION OPERATION WAS PERFORMED ON (B)(6) 2022 TO REMOVE THE BROKEN SCREWS AND RENEW THE OSTEOSYNTHESIS. THIS REPORT IS FOR AN EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 6.0 X 50MM. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: Failure of Implant
MAUDE report 15462583 ↗InjurySep 22, 2022Break; Break
DEVICE REPORT FROM SWITZERLAND REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT HAD BEEN TREATED FOR AN UNSTABLE TH 12 FRACTURE WITH EXPEDIUM VERSE AT THE HEIGHTS OF TH11-LKW 2 WITH CEMENTED SCREWS. THE OPERATION WAS COMPLETED WITHOUT DIFFICULTY OR COMPLICATIONS. DURING A POSTOPERATIVE FOLLOW-UP CHECK, IT WAS FOUND THAT BOTH SCREWS IN LKW1 WERE BROKEN NEAR THE HEAD. AS A RESULT, A REVISION OPERATION WAS PERFORMED ON (B)(6) 2022 TO REMOVE THE BROKEN SCREWS AND RENEW THE OSTEOSYNTHESIS. THIS REPORT IS FOR AN EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 6.0 X 50MM. THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: Failure of Implant
MAUDE report 15462492 ↗MalfunctionJun 24, 2021Device Slipped; Device Slipped
DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THAT THE PATIENT UNDERWENT A PRIMARY SURGERY FOR DEGENERATIVE SCOLIOSIS OF THE L2-3-4. THE PATIENT WAS IMPLANTED WITH THE EXPEDIUM VERSE AND SIX (6) PEDICLE SCREWS. THE ROD WAS PLACED ON THE LEFT AND FIXATION WAS PERFORMED USING THE CORRECTION KEY INSERTER, THREE (3) CORRECTION KEYS AND HAND TIGHTENING. THE LEFT INNER SCREWS WERE FIXATED USING A DEROTATION MANEUVER WITH THE ROD HOLDER AND HAND TIGHTENING. NEXT THE ROD WAS PLACE ON THE RIDE SIDE USING HAND THAT FIXATION WITH THREE (3) SET SCREWS. THE FINAL TIGHTENING WAS PERFORMED ON THE THREE (3) CORRECTION KEYS AND THEN THE INNER SET SCREWS WITH THE TORQUE LIMITING HANDLE AND COUNTER TORQUE. IT WAS THEN NOTICED THAT THE INNER SET SCREW ON L4 COULD NOT BE TIGHTENED AND KEPT TURNING. THE FINAL TIGHTENING OF THE SET SCREWS ON THE RIGHT SIDED ROD WAS PERFORMED AND THE REMOVAL OF THE CORRECTION KEY ON THE LEFT L4. THIS WAS REPLACED BY A SET SCREW WHICH ALSO COULD NOT BE TIGHTENED. IT WAS DISCOVERED THAT THE SCREWHEAD WAS DAMAGED. FINALLY, ALL OF THE SET SCREWS AND THE LEFT ROD WERE REMOVED SO THE L4 SCREW COULD BE REPLACED WITH A BIGGER SCREW. T
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12059629 ↗MalfunctionJun 15, 2021Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE SCREW WAS CORRECTLY PLACED IN THE PEDICLE L5 RIGHT. THE OPEN ALIGNMENT GUIDE WAS PLACED OVER THE SCREW HEAD. DURING THE FIXATION, THE SCREW HEAD DISCONNECTED FROM THE SCREW SHANK AND IT WAS FOUND IN THE OPEN ALIGNMENT GUIDE. ALL STEPS HAVE BEEN PERFORMED CORRECTLY FROM THE SURGEON. THE OPEN ALIGNMENT GUIDE ((B)(4)) AND THE OPEN ALIGNMENT SLEEVE ((B)(4)) HAVE BEEN CORRECTLY FIXED ON THE CREW HEAD AND THE SCREW HAVE BEEN REPLACED. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A TEN(10) MINUTES DELAY. CONCOMITANT DEVICE REPORTED: EXPEDIUM VERSE SPINE SYSTEM ALIGNMENT DEVICE, OPEN (PART#299704285, LOT# UNKNOWN, QUANTITY UNKNOWN). EXPEDIUM VERSE SPINE SYSTEM ALIGNMENT SLEEVE, OPEN. (PART#299704295, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1). THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12001290 ↗MalfunctionMar 16, 2021Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 THAT THE VERSE CORRECTION KEY INTERLOCKED WITH THE SCREW PLACED AT THE LEFT SIDED L5 AND BROKE DUE TO THE INTERLOCKING. THE THREAD OF THE SCREW ALSO BROKE AS A RESULT AND HAD TO BE REMOVED AND EXCHANGED. A METAL CHIP WAS REMOVED DURING REMOVAL. THE SAME THING HAPPENED ON THE RIGHT SIDE BUT THE SCREW DID NOT BREAK AND REMAINED IN THE PATIENT. THE VERSE CORRECTION KEY WAS REMOVED AND EXCHANGED FOUR (4) TIMES DURING THE PROCEDURE AND ONE (1) SCREW WAS REPLACED DURING THE PROCEDURE. THIS RESULTED IN AN TWENTY (20) MINUTE DELAY. THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE FEN SCR 6.0X50. THIS IS REPORT 6 OF 6 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11496444 ↗MalfunctionMar 16, 2021Break; Break
DEVICE REPORT FROM GERMANY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 THAT THE VERSE CORRECTION KEY INTERLOCKED WITH THE SCREW PLACED AT THE LEFT SIDED L5 AND BROKE DUE TO THE INTERLOCKING. THE THREAD OF THE SCREW ALSO BROKE AS A RESULT AND HAD TO BE REMOVED AND EXCHANGED. A METAL CHIP WAS REMOVED DURING REMOVAL. THE SAME THING HAPPENED ON THE RIGHT SIDE BUT THE SCREW DID NOT BREAK AND REMAINED IN THE PATIENT. THE VERSE CORRECTION KEY WAS REMOVED AND EXCHANGED FOUR (4) TIMES DURING THE PROCEDURE AND ONE (1) SCREW WAS REPLACED DURING THE PROCEDURE. THIS RESULTED IN AN TWENTY (20) MINUTE DELAY. THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE FEN SCR 6.0X50. THIS IS REPORT 5 OF 6 FOR PC (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11496398 ↗InjuryJan 25, 2021Break; Break
CONCOMITANT DEVICE REPORTED: 5.5 EXP VERSE UNITIZED SET SCR (PART# 199721001, LOT# TN1332, QUANTITY 4). MMSI ROD PREBENT, 5.5 X45MM, T (PART# 179772045, LOT# BDK3HSM, QUANTITY 2). 5.5 EXP VERSE FEN SCR 6.0X50 (PART# 199723650, LOT# 106721, QUANTITY 2).
Patient problems: Failure of Implant
MAUDE report 11224001 ↗InjuryJan 25, 2021Break; Break
CONCOMITANT DEVICE REPORTED: 5.5 EXP VERSE UNITIZED SET SCR (PART# 199721001, LOT# TN1332, QUANTITY 4). MMSI ROD PREBENT, 5.5 X45MM, T (PART# 179772045, LOT# BDK3HSM, QUANTITY 2). 5.5 EXP VERSE FEN SCR 6.0X50 (PART# 199723650, LOT# UNKNOWN, QUANTITY 2).
Patient problems: Failure of Implant
MAUDE report 11223970 ↗InjuryJan 25, 2021Break; Break
CONCOMITANT DEVICE REPORTED: 5.5 EXP VERSE UNITIZED SET SCR (PART# 199721001, LOT# TN1332, QUANTITY 4). MMSI ROD PREBENT, 5.5 X45MM, T (PART# 179772045, LOT# BDK3HSM, QUANTITY 2). 5.5 EXP VERSE FEN SCR 6.0X50 (PART# 199723650, LOT# UNKNOWN, QUANTITY 2).
Patient problems: Failure of Implant
MAUDE report 11223946 ↗InjuryDec 9, 2020Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGEON STATED A REVISION SURGERY IS REQUIRED TO REMOVE A BROKEN PEDICLE SCREW FROM A PATIENT. THE ORIGINAL OPERATION WAS COMPLETED ON (B)(6) 2017. THERE IS NO FURTHER INFORMATION AVAILABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). UNKNOWN SETSCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE FEN SCR 6.0X50. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: Failure of Implant
MAUDE report 10976586 ↗InjurySep 24, 2020Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE VERSE ADVANCED SCREWS BROKE IN THE VERTEBRAL BODY POST-OPERATION. THERE IS NO FURTHER INFORMATION AVAILABLE. CONCOMITANT DEVICE REPORTED: VERSE CORRECTION KEY (PART# 199721000 , LOT# 206919, QUANTITY 1); VERSE CORRECTION KEY (PART# 199721000 , LOT# 196158, QUANTITY 1); VERSE CORRECTION KEY (PART# 199721000 , LOT# 190651, QUANTITY 1); VERSE CORRECTION KEY (PART# 199721000 , LOT# 190159, QUANTITY 1); 5.5 EXP VERSE FEN SCR 6.0X45 (PART# 199723645, LOT# 155845, QUANTITY 1); 5.5 EXP VERSE FEN SCR 6.0X45 (PART# 199723645, LOT# 184191, QUANTITY 1); 5.5 EXP VERSE FEN SCR 6.0X45 (PART# 199723645, LOT# 175103, QUANTITY 1); 5.5 EXP VERSE FEN SCR 6.0X45 (PART# 199723645, LOT# 184192, QUANTITY 1). THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE FEN SCR 6.0X50. THIS IS REPORT 2 OF 8 FOR (B)(4).
Patient problems: Failure of Implant; No Code Available; Spinal Column Injury
MAUDE report 10580942 ↗InjuryFeb 12, 2019Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT DURING A REVISION SURGERY 2 OF 4 VERSE INNIES WERE FOUND LOOSE BESIDE THE CONSTRUCT AND 4 VERSE SCREWS SEEMED LOOSE AS WELL. ALREADY IN THE REOP X-RAY THE INNIES SEEMED NOT TIGHTENED AND THE SCREWS LOOSE.
Patient problems: No Code Available
MAUDE report 8333590 ↗InjuryDec 11, 2017Break; Break
L3/5 PLF REVISION SURGERY PLANNED FOR (B)(6) 2017 (REMOVE/REPLACE BROKEN RIGHT L5 SCREW, DR (B)(6), PRIVATE HOSPITAL. PRIMARY IMPLANT DATE (B)(6) 2017. REPORT CAME THROUGH OF A BROKEN SCREW IN SITU. RIGHT L5 SCREW. ID: (B)(4), FEMALE PATIENT (B)(6).
Patient problems: Spinal Column Injury
MAUDE report 7105248 ↗InjuryNov 8, 2017Loose or Intermittent Connection; Loose or Intermittent Connection
L4/S1 POSTERIOR STABILISATION. PATIENT PRESENTED FOR ROUTINE 3 MONTH POST OP. FOLLOW UP, COMPLAINING OF BACK PAIN. UPON INVESTIGATION, THE IMAGING REVEALED THAT THE CONSTRUCT RODS HAD MIGRATED CRANIALLY, AND ARE COMPLETELY OUT OF THE S1 SCREWS. THIS IS EVIDENT WHEN COMPARING THE CONSTRUCT TO THE IMAGE TAKEN IMMEDIATELY POST OP.
Patient problems: Failure of Implant
MAUDE report 7008952 ↗InjuryOct 30, 2017Loose or Intermittent Connection; Loose or Intermittent Connection
L4/S1 POSTERIOR STABILISATION. PATIENT PRESENTED FOR ROUTINE 3 MONTH POST OP. FOLLOW UP, COMPLAINING OF BACK PAIN. UPON INVESTIGATION, THE IMAGING REVEALED THAT THE CONSTRUCT RODS HAD MIGRATED CRANIALLY, AND ARE COMPLETELY OUT OF THE S1 SCREWS. THIS IS EVIDENT WHEN COMPARING THE CONSTRUCT TO THE IMAGE TAKEN IMMEDIATELY POST OP.
Patient problems: Failure of Implant
MAUDE report 6988277 ↗
Other ORTHOSIS, SPINAL PEDICLE FIXATION devices
- NA 04.614.508Synthes GmbH · ORTHOSIS, SPINAL PEDICLE FIXATION277 reports
- CREO 1134.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION112 reports
- CREO 1119.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION80 reports
- VIPER 186731745Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION43 reports
- CD HORIZON® Spinal System 1553201090Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION38 reports
- EXPEDIUM 179902000Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION37 reports
- CD HORIZON® Spinal System 7540220Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION36 reports
- EXPEDIUM VERSE 199721640Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION35 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page