EXPEDIUM 179712750Recalls & reported problems
Medos International Sàrl · EXPEDIUM SPINE SYSTEM SI POLYAXIAL SCREW 5.5 x 7 x 50mm · Class 2 · Implant
All models of EXPEDIUM (291)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This is a Medos International Expedium polyaxial pedicle screw, a screw used to hold the spine together during fusion surgery. The 30 reports mostly describe the screw breaking or shifting after implantation, along with loosening of the joint, nerve damage, and bone loss around the implant, with several patients needing repeat surgery. There are 25 injuries and no deaths. No recalls name this device, and reports have fallen sharply, from 2 in the previous 12 months to none.
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
- 30
- Deaths reported
- 0
- Injuries reported
- 25
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10705034067919), received between Sep 14, 2017 and Aug 22, 2025 — classified as 25 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Break” (13 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
- Break13
- Adverse Event Without Identified Device or Use Problem6
- Migration4
- Appropriate Device Problem Term/Code Not Available2
- Compatibility Problem2
- Material Twisted/Bent2
- Device-Device Incompatibility1
- Insufficient Device Problem Information1
Patient problems
- Joint Laxity5
- Nerve Damage5
- Osteolysis5
- Insufficient Information4
- No Clinical Signs, Symptoms or Conditions4
- No Code Available4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Failure of Implant3
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
InjuryAug 22, 2025Break; Break
IT WAS REPORTED THAT ON (B)(6), 2024, PATIENT UNDERWENT L5-S1 CENTRAL DECOMPRESSION SURGERY WITH BILATERAL L5-S1 NERVE ROOT DECOMPRESSION, L5-S1 POSTERIOR SPINAL FUSION, AND L5-SI POSTERIOR SPINAL SEGMENTAL INSTRUMENTATION. AS PART OF THIS PROCEDURE, PATIENT WAS IMPLANTED WITH EXPEDIUM PEDICLE SCREWS. AT A POST-OPERATIVE VISIT WITH HIS SURGEON ON (B)(6), 2024, PATIENT REPORTED THAT ABOUT TWO WEEKS PRIOR TO THE VISIT HE FELT A POP IN HIS LOW BACK WHEN HE STEPPED AROUND AN OBJECT. AN X-RAY TAKEN AT THE (B)(6), 2024, POST-OP VISIT SHOWED THAT THE LEFT L4 PEDICLE SCREW WAS FRACTURED AT THE BASE OF THE MULTIAXIAL CONNECTOR. BASED ON THE HOPE THAT THE FUSION WOULD NEVERTHELESS PROCEED TO FULL CONSOLIDATION, PATIENT'S SURGEON RECOMMENDED NO SURGICAL INTERVENTION AT THAT TIME. (THE SURGEON CORRECTED HIS ANATOMICAL NOMENCLATURE TO L5 IN A SUBSEQUENT VISIT OF (B)(6) 2024, CONSISTENT WITH HIS OPERATIVE REPORT OF 3/27/24.) AT A POST-OPERATIVE VISIT WITH HIS SURGEON ON (B)(6), 2024, X-RAYS SHOWED THAT THE ANTERIOR DISPLACEMENT OF HIS L4 VERTEBRA ON THE L5 VERTEBRA HAD INCREASED FROM 3 MM (AS OF THE (B)(6) 24 VISIT) TO 9 MM. CONTINUED OBSERVATION WAS AGAIN RECOMMENDED BY PATIENT'S SURGEON. (THE
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 22873388 ↗InjuryAug 21, 2025Break; Break
ON (B)(6) 2024, PATIENT UNDERWENT L5-S1 CENTRAL DECOMPRESSION SURGERY WITH BILATERAL L5-S1 NERVE ROOT DECOMPRESSION, L5-S1 POSTERIOR SPINAL FUSION, AND L5-SI POSTERIOR SPINAL SEGMENTAL INSTRUMENTATION. AS PART OF THIS PROCEDURE, PATIENT WAS IMPLANTED WITH EXPEDIUM PEDICLE SCREWS. AT A POST-OPERATIVE VISIT WITH HIS SURGEON ON (B)(6) 2024, PATIENT REPORTED THAT ABOUT TWO WEEKS PRIOR TO THE VISIT HE FELT A POP IN HIS LOW BACK WHEN HE STEPPED AROUND AN OBJECT. AN X-RAY TAKEN AT THE (B)(6) 2024, POST-OP VISIT SHOWED THAT THE LEFT L4 PEDICLE SCREW WAS FRACTURED "AT THE BASE OF THE MULTIAXIAL CONNECTOR." BASED ON THE HOPE THAT THE FUSION WOULD NEVERTHELESS "PROCEED TO FULL CONSOLIDATION," PATIENT'S SURGEON RECOMMENDED NO SURGICAL INTERVENTION AT THAT TIME. (THE SURGEON CORRECTED HIS ANATOMICAL NOMENCLATURE TO L5 IN A SUBSEQUENT VISIT OF (B)(6) 2024, CONSISTENT WITH HIS OPERATIVE REPORT OF (B)(6) 2024.) AT A POST-OPERATIVE VISIT WITH HIS SURGEON ON (B)(6) 2024, X-RAYS SHOWED THAT THE ANTERIOR DISPLACEMENT OF HIS L4 VERTEBRA ON THE L5 VERTEBRA HAD INCREASED FROM 3 MM (AS OF THE (B)(6) 2024 VISIT) TO 9 MM. CONTINUED OBSERVATION WAS AGAIN RECOMMENDED BY PATIENT'S SURGEON. (THE SURGEON CORRECT
Patient problems: Pain
MAUDE report 22868944 ↗InjuryJan 5, 2024Migration; Migration
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: IMPLANT MALPOSITION, INSTABILITY, NON-UNION, POSTOPERATIVE INFECTION DEEP COMPLICATION TIME/INTERVENTION REPEAT SURGERY THIS REPORT IS FOR ONE (1) SI POLYAXL SCREW 7 X 50MM THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).
Patient problems: Insufficient Information; Joint Laxity; Nonunion/Delayed-union Bone Fracture; Unspecified Infection
MAUDE report 18455952 ↗InjuryJan 5, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
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: IMPLANT FAILURE, INSTABILITY, NON-UNION. COMPLICATION TIME/INTERVENTION. REPEAT SURGERY. THIS REPORT IS FOR ONE (1) SI POLYAXL SCREW 7 X 50MM. THIS IS REPORT 4 OF 4 FOR COMPLAINT PC-(B)(4).
Patient problems: Joint Laxity; Nonunion/Delayed-union Bone Fracture
MAUDE report 18451435 ↗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: ADJACENT SEGMENT PATHOLOGY, NEUROCOMPRESSION COMPLICATION TIME/INTERVENTION REPEAT SURGERY THIS IS FOR DEPUY SYNTHES SPINE EXPEDIUM /OTHER, MOSS MIAMI SI /OTHER AND EXPEDIUM POLYAXIAL PRODUCTS. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).
Patient problems: Nerve Damage; Osteolysis
MAUDE report 18451090 ↗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: INSTABILITY, NEUROCOMPRESSION. COMPLICATION TIME/INTERVENTION. REPEAT SURGERY. THIS REPORT IS FOR ONE (1) SI POLYAXL SCREW 7 X 50MM. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).
Patient problems: Joint Laxity; Nerve Damage
MAUDE report 18447579 ↗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, INSTABILITY, NEURO COMPRESSION, SPINAL IMBALANCE COMPLICATION TIME/INTERVENTION. REPEAT SURGERY THIS IS FOR DEPUY SYNTHES SPINE EXPEDIUM POLYAXIAL AND MOSS MIAMI SI /OTHER PRODUCTS (SI POLYAXL SCREW 7 X 50MM (B)(4).
Patient problems: Joint Laxity; Nerve Damage; Osteolysis
MAUDE report 18447529 ↗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, INSTABILITY, NEUROCOMPRESSION, OTHER. COMPLICATION TIME/INTERVENTION. REPEAT SURGERY. THIS IS FOR DEPUY SYNTHES SPINE EXPEDIUM /OTHER AND EXPEDIUM POLYAXIAL AND MOSS MIAMI SI /OTHER PRODUCTS (SI POLYAXL SCREW 7 X 50MM (B)(4).
Patient problems: Insufficient Information; Joint Laxity; Nerve Damage; Osteolysis
MAUDE report 18446303 ↗MalfunctionDec 20, 2023Compatibility Problem; Compatibility Problem
THERE WAS A SURGICAL DELAY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT IS IN GOOD CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18366874 ↗MalfunctionDec 20, 2023Compatibility Problem; Compatibility Problem
THERE WAS A SURGICAL DELAY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT IS IN GOOD CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18366873 ↗InjuryJun 28, 2023Break; Break
IT WAS REPORTED THAT ON MAY 16, 2023, THERE WERE 2 SPINE SCREWS THAT WERE IN QUESTION. IT WAS FOUND THAT THE SCREWS WERE BROKEN. THE BROKEN HARDWARE WAS REMOVED FROM THE PATIENT. THIS REPORT INVOLVES ONE (1) EXPEDIUM SPINE SYSTEM SI POLYAXIAL SCREW 5.5 X 7 X 50MM. THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: Failure of Implant
MAUDE report 17216435 ↗MalfunctionAug 4, 2022Material Twisted/Bent; Material Twisted/Bent
DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, A SCREW WAS INSERTED IN THE PEDICLE, BAR AND TOP WERE PLACED WITHOUT TORSION. DURING TIGHTENING THE INTERNAL SCREW DID NOT LOWER AND IT WAS TWISTED, SO ANOTHER INTERNAL SCREW WAS TRIED AND THE SAME HAPPENED. THE BAR WAS REMOVED AND IT WAS OBSERVED THAT THE SCREW HAD THE HEAD WITH THE INTERNAL PART TWISTED WHICH PREVENTED THE CORRECT CLOSING OF THE SYSTEM. IN THE TIGHTENING OPERATION WITH THE NEW SCREW, THE SCREWDRIVERS WERE ALSO TWISTED. THE SURGERY WAS COMPLETED WITHOUT FURTHER INCONVENIENCE AND WITHOUT AFFECTING THE PATIENT. THIS REPORT IS FOR ONE (1) SI POLYAXL SCREW 7 X 50MM THIS IS REPORT 1 OF 6 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15165418 ↗InjuryJan 5, 2022Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT UNDERWENT THE REVISION PROCEDURE ON (B)(6) 2021 DUE TO BROKEN SCREW. THE SCREW FRACTURED AT THE SHAFT RIGHT UNDER THE POLYAXIAL SCREWHEAD. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) EXPEDIUM SPINE SYSTEM SI POLYAXIAL SCREW 5.5 X 7 X 50MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 13172577 ↗InjuryDec 8, 2021Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, PROCEDURE WAS REVISED DUE TO BACK PAIN AND CONNECTION DEGENERATION. THIS REPORT IS FOR ONE (1) SI POLYAXL SCREW 7 X 45MM. THIS IS REPORT 4 OF 7 FOR COMPLAINT (B)(4).
Patient problems: Osteolysis; Pain
MAUDE report 12961916 ↗MalfunctionOct 21, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 THAT IT WAS NOT POSSIBLE TO SCREW THE INNIE INTO THE SCREW HEAD. AFTER REMOVING THE SCREW, IT WAS DISCOVERED THAT THERE WAS DAMAGE TO THE THREAD IN THE SCREW HEAD. THERE WAS A FIVE (5) MINUTE SURGICAL DELAY WHILE THE DEFECTIVE SCREW WAS REPLACED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICE REPORTED: UNKNOWN INNIE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) SI POLYAXL SCREW 7 X 50MM. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12673104 ↗InjurySep 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS CASE IS BEING LOGGED TO CAPTURE THE REVISION ASSOCIATED WITH (B)(4) WHICH RECEIVED AS ADDITIONAL INFORMATION. IT WAS REPORTED THAT, THE REVISION OF POSTERIOR LUMBAR SPINAL FUSION WAS PERFORMED. THE REASON FOR REVISION WAS ADJACENT SEGMENT DEGENERATION/ADJACENT LEVEL DISEASE. THE EXPLANTED PRODUCTS WERE EXPEDIUM PEDICLE SCREWS AND CFX SCREWS, BUT THE LOT NUMBERS ARE NOT AVAILABLE. THE IMPLANTS WERE DISCARDED AND NOT AVAILABLE FOR COLLECTION. THIS REPORT IS FOR ONE (1) EXPEDIUM SPINE SYSTEM SI POLYAXIAL SCREW 5.5 X 7 X 50MM. THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: Osteolysis
MAUDE report 12433471 ↗InjuryAug 18, 2021Migration; Migration
DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON JULY 20, 2021, PATIENT UNDERWENT REVISION SURGERY DUE TO PULL-OUT OF TWO SCREWS. DURING THE PROCEDURE, THERE WAS A SMALL CEMENT LEAKAGE IN THE CANAL DURING THE INTRODUCTION OF THE CONFIDENCE CEMENT. RADIOLOGICALLY, THE CEMENT DID NOT COME OUT OF THE HOLES ON THE IMPLANTED SCREW. THIS REPORT IS FOR A SI POLYAXL SCREW 7 X 50MM. THIS IS REPORT 2 OF 2 FOR (B)(4) AND CAPTURES THE REQUIRED REVISION SURGERY. THE CEMENT LEAKAGE IS CAPTURED UNDER (B)(4).
Patient problems: Insufficient Information
MAUDE report 12338856 ↗InjuryAug 18, 2021Migration; Migration
DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT REVISION SURGERY DUE TO PULL-OUT OF TWO SCREWS. DURING THE PROCEDURE, THERE WAS A SMALL CEMENT LEAKAGE IN THE CANAL DURING THE INTRODUCTION OF THE CONFIDENCE CEMENT. RADIOLOGICALLY, THE CEMENT DID NOT COME OUT OF THE HOLES ON THE IMPLANTED SCREW. THIS REPORT IS FOR A SI POLYAXL SCREW 7 X 50MM. THIS IS REPORT 1 OF 2 FOR (B)(4) AND CAPTURES THE REQUIRED REVISION SURGERY. THE CEMENT LEAKAGE IS CAPTURED UNDER (B)(4).
Patient problems: Insufficient Information
MAUDE report 12338836 ↗InjuryJul 21, 2021Break; Break
IT WAS REPORTED THAT ON (B)(6) 2021, A REVISION SURGERY WAS PERFORMED TO EXTEND THE CONSTRUCT UP. UPON OPENING, IT WAS NOTICED THAT METALLOSIS HAD OCCURRED. THE HEADS OF THE PEDICLE SCREWS AT T11 AND T12 ON THE RIGHT HAD DISLODGED AND BROKEN OFF OF THE SCREWS. IT WAS ALSO OCCURRED WITH THE LEFT SACRAL SCREW. THE PREVIOUS CONSTRUCT WAS FROM T10-PELVIS. THIS REPORT IS FOR ONE (1) SI POLYAXIAL SCREW 5.5 X 7 X 50MM. THIS IS REPORT 5 OF 6 FOR (B)(4).
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12205090 ↗InjuryJul 21, 2021Break; Break
IT WAS REPORTED THAT ON (B)(6) 2021, A REVISION SURGERY WAS PERFORMED TO EXTEND THE CONSTRUCT UP. UPON OPENING, IT WAS NOTICED THAT METALLOSIS HAD OCCURRED. THE HEADS OF THE PEDICLE SCREWS AT T11 AND T12 ON THE RIGHT HAD DISLODGED AND BROKEN OFF OF THE SCREWS. IT WAS ALSO OCCURRED WITH THE LEFT SACRAL SCREW. THE PREVIOUS CONSTRUCT WAS FROM T10-PELVIS. THIS REPORT IS FOR ONE (1) SI POLYAXIAL SCREW 5.5 X 7 X 50MM. THIS IS REPORT 2 OF 6 FOR (B)(4).
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12204973 ↗InjuryDec 10, 2019No Apparent Adverse Event; No Apparent Adverse Event
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT SURGERY FOR THE EXTENSION OF THE SPONDYLODESIS TO L3 BECAUSE OF ADJACENT SEGMENT DEGENERATION AND STENOSIS. PREVIOUS SURGERY FOR SPONDYLODESIS/FUSION L4-S1 WAS DONE ON 2015. THE PROCEDURE AND PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES UNKNOWN NUMBER OF DEVICES. THIS COMPLAINT IS FOR ONE (1) SINGLE INNER POLYAXIAL SCREW 5.5 X 7.00 X 50MM. THIS REPORT IS 4 OF 4 FOR (B)(4).
Patient problems: No Code Available
MAUDE report 9444132 ↗InjuryDec 6, 2019Migration; Migration
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A EXPEDIUM SCREW HEAD BROKEN OFF. THE PATIENT HAD A PREVIOUS SURGERY, SPONDYLODESIS/ FUSION L4-S1 IN 2015. THE SURGERY WAS AN EXTENSION OF THE SPONDYLODESIS TO L3 BECAUSE OF ADJACENT SEGMENT DEGENERATION AND STENOSIS. AS THE RODS WERE REMOVED AND THE SCREWS TESTED FOR STABILITY THE SCREW HEAD OF S1 LEFT WAS LOOSE/ BROKEN. NO SIGNS FOR PSEUDARTHROSIS. THE BROKEN OFF SCREW SHAFT WAS LEFT IN THE VERTEBRA AND THE NEW CONSTRUCT CONNECTED FROM L3 TO L5 ON THE LEFT SIDE AND L3 TO S1 ON THE RIGHT SIDE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED, HOWEVER, FRAGMENTS WERE GENERATED AND WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. NO PATIENT CONSEQUENCES. THERE WILL BE ONLY ONE SCREW HEAD RETURNED. THE REST OF THE IMPLANTS WAS DISCARDED AFTER SURGERY. CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).
Patient problems: Foreign Body In Patient
MAUDE report 9430510 ↗InjuryApr 26, 2019Break; Break
IT WAS REPORTED THAT A REVISION SURGERY NECESSARY DUE TO BROKEN SCREWS POSTOPERATIVE. INITIAL SURGERY ON (B)(6) 2017 DORSAL L3-L5. REVISION SURGERY TOOK PLACE ON (B)(6) 2019. EXACT DATE WHEN SCREW BROKE OFF IS UNKNOWN.
Patient problems: No Code Available
MAUDE report 8556633 ↗InjuryApr 25, 2019Break; Break
IT WAS REPORTED THAT A REVISION SURGERY NECESSARY DUE TO BROKEN SCREWS POSTOPERATIVE. INITIAL SURGERY ON (B)(6) 2017 DORSAL L3-L5. REVISION SURGERY TOOK PLACE ON (B)(6) 2019. EXACT DATE WHEN SCREW BROKE OFF IS UNKNOWN.
Patient problems: No Code Available
MAUDE report 8552395 ↗InjuryApr 25, 2019Break; Break
IT WAS REPORTED THAT A REVISION SURGERY NECESSARY DUE TO BROKEN SCREWS POSTOPERATIVE. INITIAL SURGERY ON (B)(6) 2017 DORSAL L3-L5. REVISION SURGERY TOOK PLACE ON (B)(6) 2019. EXACT DATE WHEN SCREW BROKE OFF IS UNKNOWN.
Patient problems: No Code Available
MAUDE report 8552299 ↗
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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.
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