PASS LPRecalls & reported problems across all models
Medicrea International · 16 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one PASS LP model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 18
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 1
We found 16 models of PASS LP by Medicrea International in the FDA's device registry (GUDID). Together they are named in 18 adverse event reports in the FDA's MAUDE database, received between Nov 26, 2021 and Feb 16, 2026 — classified as 4 injuries, 14 malfunctions.
The most frequently reported specific device problem is “Break” (12 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
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
PASS LP recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jul 12, 2023Open, Classified
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
Z-2458-2023 · Root cause: Under Investigation by firm · names 11 of these models · Recall details · FDA record ↗
Most reported PASS LP problems
Device problems
- Break12
- Material Deformation4
- Adverse Event Without Identified Device or Use Problem3
- Detachment of Device or Device Component1
- Failure to Align1
Patient problems
- No Clinical Signs, Symptoms or Conditions13
- Bone Fracture(s)1
- Device Embedded In Tissue or Plaque1
- Fever1
- Inflammation1
- Sepsis1
- Stenosis1
- Unspecified Infection1
PASS LP models
16 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PASS LP B02316545ZOrthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease1 recall3 reports
- PASS LP B02315535ZOrthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease1 recall0 reports
- PASS LP B02315540ZOrthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease1 recall0 reports
- PASS LP B02315545ZOrthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease1 recall0 reports
- PASS LP B02315550ZOrthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease1 recall0 reports
- PASS LP B02316535ZOrthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease1 recall0 reports
- PASS LP B02316540ZOrthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease1 recall0 reports
- PASS LP B02316550ZOrthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease1 recall0 reports
- PASS LP B02317540ZOrthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease1 recall0 reports
- PASS LP B02317545ZOrthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease1 recall0 reports
- PASS LP B02317550ZOrthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease1 recall0 reports
- PASS LP A02210100Screwdriver6 reports
- PASS LP A02230250Orthopedic Manual Surgical Instrument4 reports
- PASS LP A01130250Screwdriver3 reports
- PASS LP B02216545Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease1 report
- PASS LP A02230020Screwdriver1 report
Recent PASS LP adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionFeb 16, 2026Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL SCREW RE MOVAL PROCEDURE AT THE L4 LEVEL. IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE WHILE BEING USED TO FACILITATE THE REMOVAL OF AN IMPLANTED SCREW. THE INSTRUMENT WAS APPLIED TO THE TOP OF THE SCREW WITH DOWNWARD PRESSURE TO BACK THE SCREW OUT, WHICH REQUIRED A GREAT DEAL OF FORCE, AND THE TIP BROKE AS A RESULT. NO FRAGMENTS REMAINED IN THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24342665 ↗MalfunctionFeb 11, 2026Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL SCREW REMOVAL PROCEDURE AT THE L4 LEVEL. IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE WHILE BEING USED TO FACILITATE THE REMOVAL OF AN IMPLANTED SCREW. THE INSTRUMENT WAS APPLIED TO THE TOP OF THE SCREW WITH DOWNWARD PRESSURE TO BACK THE SCREW OUT, WHICH REQUIRED A GREAT DEAL OF FORCE, AND THE TIP BROKE AS A RESULT. NO FRAGMENTS REMAINED IN THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24312876 ↗MalfunctionDec 11, 2025Material Deformation; Material Deformation
INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT DURING A NORMAL CHECK-IN, THE TIP OF THE DRIVER WAS OBSERVED TO BE ROUNDING OFF. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23786061 ↗MalfunctionSep 4, 2025Material Deformation; Material Deformation
INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT BOTH THE INSTRUMENT TORX SHAFT AND THE DRIVER WERE STRIPPED. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22962265 ↗MalfunctionJan 19, 2025Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP OF THE REPORTED PRODUCT. IT WAS REPORTED THAT, THE DRIVER WAS BROKEN DURING THE REMOVAL OF METAL WORK. THERE WERE NO REMAINING PIECES INSIDE THE PATIENT AND NO ISSUES OR PROBLEM WITH THE PATIENT. THE DRIVER WAS USED ACCORDING TO THE PROVIDED IFU AND LABELLING. NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT. NO FURTHER COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21187911 ↗MalfunctionJan 19, 2025Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR REMOVAL OF PEDICLE SCREWS. IT WAS REPORTED THAT, WHEN ATTEMPTING TO REMOVE IMPLANTED SCREWS, THE DISTAL TIP TORQUED AND RIPPED OFF. THE TIPS OF THE DRIVERS WERE BROKEN. THERE WAS NO FRAGMENT OF BROKEN INSTRUMENT REMAINS IN PATIENT BODY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED. NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21187838 ↗MalfunctionJan 19, 2025Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR REMOVAL OF PEDICLE SCREWS. IT WAS REPORTED THAT, WHEN ATTEMPTING TO REMOVE IMPLANTED SCREWS, THE DISTAL TIP TORQUED AND RIPPED OFF. THE TIPS OF THE DRIVERS WERE BROKEN. THERE WAS NO FRAGMENT OF BROKEN INSTRUMENT REMAINS IN PATIENT BODY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED. NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21187836 ↗MalfunctionJan 19, 2025Break; Break
INFORMATION WAS RECEIVED FROM USER FACILITY VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING PRIOR TO USE OF THE REPORTED PRODUCT. IT WAS REPORTED THAT, THE PROBLEM WAS NOTICED PRE OP THAT ONE OF THE TEETH IS BROKEN OFF. THERE WAS NO PATIENT INVOLVED DURING THIS EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21187819 ↗MalfunctionJan 11, 2025Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA A USER REPORT REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE PATIENT WAS TREATED FOR REMOVAL OF MATERIAL AND ENLARGEMENT OF LUMBOSACRAL MOUNT AND 2 OUT OF 4 NOTCHES OF THE DRIVER BROKE ONE AFTER THE OTHER WHEN THE OLD CAPS WERE LOOSENED. ONLY ONE NOTCH COULD BE REMOVED WITH CERTAINTY AND IT WAS UNCERTAIN WHETHER THE SECOND NOTCH WAS REMOVED. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 21133019 ↗MalfunctionJan 11, 2025Break; Detachment of Device or Device Component; Material Deformation; Break; Detachment of Device or Device Component; Material Deformation
INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE DRIVER WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21132950 ↗MalfunctionDec 9, 2024Break; Failure to Align; Break; Failure to Align
INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR PLF. IT WAS REPORTED THAT THE DRIVER WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE EVENT. THE TIP OF THE DRIVER WAS NOT ABLE TO FULLY CONNECT WITH SCREW HEADS. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20876100 ↗MalfunctionJun 10, 2024Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING REVISION SURGERY FOR EXTENSION DUE TO VERTEBRAL FRACTURE. IT WAS REPORTED THAT WHEN REMOVING A CROSSLINK IN A REVISION SPINE PROCEDURE, THE TIP OF THE T20 DRIVER SHEARED OFF IN THE IMPLANT. THE SHARD WAS RECOVERED AND WAS NOT LEFT IN THE PATIENT. A SECOND DRIVER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19496346 ↗MalfunctionMay 21, 2024Material Deformation; Material Deformation
INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REP ORTED THAT THE T20 SCREW NEAR BARREL, ATTACHING DRIVER PIECES TOGETHER IS STUCK/STRIPPED. IT CANNOT BE SCREWED BACK INTO TO STABILIZE THE DRIVER PIECES. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19356884 ↗MalfunctionMay 1, 2024Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. PRE-OP DIAGNOSIS OF PATIENT WAS PROXIMAL JUNCTIONAL KYPHOSIS. IT WAS REPORTED THAT THE DEVICE WAS BROKEN. THE PEDICLE SCREWDRIVER WAS BEING USED TO EXPLANT PREVIOUSLY IMPLANTED SCREWS BY ENGAGING THE BASE OF THE SCREW, AND WITH DOWNWARD PRESSURE, BACK THE SCREWS OUT. WHEN ATTEMPTING TO ENGAGE AND REMOVE THE SCREW, THE DISTAL TIP OF THE DRIVER SHEARED OFF. A SECOND DRIVER WAS SUBSEQUENTLY USED TO COMPLETE THE EXPLANTATION. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19219296 ↗InjuryJan 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER, CLINICAL STUDY VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING POST-OP OF THE REPORTED PRODUCT. IT WAS REPORTED THAT, PATIENT HAD ADJACENT LEVEL STENOSIS AT L3-L4 REGION. AS A RESULT, SUBJECT WAS HOSPITALIZED AND CONCOMITANT MEDICATION - CORTICOSTEROIDS WERE ADMINISTERED. THE ADVERSE EVENT WAS TREATED BY PERFORMING ADDITIONAL DECOMPRESSION AND OSTEOSYNTHESIS AT L3-L4. THERE WAS NO ALLEGATION/MALFUNCTION ASSOCIATED WITH REPORTED PASS DEGEN SCREWS. THE LEVELS IMPLANTED WERE L4-L5. INVESTIGATOR ASSESSMENT STATES, THE AE WAS CAUSALLY RELATED TO STUDY PROCEDURE AND NOT RELATED TO STUDY DEVICE AND UNKNOWN TO INSTRUMENTS. SPONSOR ASSESSMENT STATES, THE AE WAS NOT RELATED TO STUDY PROCEDURE AND INSTRUMENTS. POSSIBLY RELATED TO STUDY DEVICE. START DATE OF THE HOSPITALIZATION: (B)(6) 2023 END DATE OF THE HOSPITALIZATION: 07/DEC/2023 DATE OF ADDITIONAL SURGERY IN THE SPINE: (B)(6) 2023 PROXIMAL INSTRUMENTED VERTEBRA: L3 DISTAL INSTRUMENTED VERTEBRA: L5 DATE AE FIRST DETERMINED TO BE AN SAE: (B)(6) 2023.
Patient problems: Stenosis
MAUDE report 18515841 ↗
Other Medicrea International products
All Medicrea International 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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