LineSiderRecalls & reported problems across all models
Integrity Implants Inc. · 71 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls
- 4
We found 71 models of LineSider by Integrity Implants Inc. in the FDA's device registry (GUDID). Together they are named in 9 adverse event reports in the FDA's MAUDE database, received between Aug 24, 2020 and Aug 9, 2024 — classified as 6 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 reports).
4 FDA recall records name at least one of these models by its device identifier.
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
LineSider 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.
- Aug 3, 2022Class IITerminated
Potential for intraoperative screw head separation at weld location.
Z-0421-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Jan 27, 2022Class IITerminated
Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head component, which would result in the separation of the Tulip Head from the Screw Shank.
Z-0420-2023 · Root cause: Device Design · names 24 of these models · Recall details · FDA record ↗
- Jan 27, 2022Class IITerminated
Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head component, which would result in the separation of the Tulip Head from the Screw Shank.
Z-0419-2023 · Root cause: Device Design · names 23 of these models · Recall details · FDA record ↗
- Jan 27, 2022Class IITerminated
Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head component, which would result in the separation of the Tulip Head from the Screw Shank.
Z-0418-2023 · Root cause: Device Design · names 23 of these models · Recall details · FDA record ↗
Most reported LineSider problems
Device problems
- Detachment of Device or Device Component3
- Fracture3
- Material Separation1
- Migration1
- Migration or Expulsion of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- Foreign Body In Patient1
- Vertebral Fracture1
LineSider models
71 models, most reported first. Each model has its own page with its reports, recalls and device details.
- LineSider LS-N6SA7550Thoracolumbosacral Pedicle Screw System2 recalls1 report
- LineSider LS-N6SA6545Thoracolumbosacral Pedicle Screw System2 recalls0 reports
- LineSider LS-N6MG7545Thoracolumbosacral Pedicle Screw System1 recall2 reports
- LineSider LS-N6SG6550Thoracolumbosacral Pedicle Screw System1 recall1 report
- LineSider LS-N6SG7545Thoracolumbosacral Pedicle Screw System1 recall1 report
- LineSider LS-N6SG5535Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6SG5540Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6SG5545Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6SG5550Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6SG5555Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6SG6535Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6SG6540Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6SG6545Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6SG6555Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6SG6560Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6SG7535Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6SG7550Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6SG7555Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6SG7560Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6SG8535Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6SG8540Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6SG8545Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6SG8550Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6SG8555Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6SG8560Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6MG7535Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6MG7540Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6MG7550Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6MG7555Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6MG8535Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6MG8540Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6MG8545Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6MG8550Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6MG8555Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6MG9535Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6MG9540Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6MG9545Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6MG9550Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6MG9555Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6SA5535Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6SA5540Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6SA5545Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6SA5550Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6SA5555Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6SA6535Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6SA6540Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6SA6550Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6SA6555Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6SA6560Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6SA7535Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6SA7540Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6SA7545Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6SA7555Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6SA7560Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6SA8535Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6SA8540Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6SA8545Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6SA8550Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6SA8555Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6SA8560Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6MG5535Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6MG5540Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6MG5545Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6MG5550Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6MG6535Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6MG6540Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6MG6545Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6MG6550Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6MG6555Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-TU7S5560Thoracolumbosacral Pedicle Screw System3 reports
- LineSider LS-SC7G6550Thoracolumbosacral Pedicle Screw System1 report
Recent LineSider adverse event reports
The 9 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryAug 9, 2024Material Separation; Material Separation
ON 12-JUL-2024, ACCELUS WAS MADE AWARE OF AN ISSUE WITH AN IMPANT THAT A TULIP CAME OFF A SHANK CAUSING FAILURE. IT HAD SEPARATED. A REVISION SURGERY WAS NEEDED DUE TO PATHOLOGY / FRACTURE THAT OCCURRED DUE TO HARDWARE FAILURE FROM THE FIRST SURGERY AND IT IS UNKNOWN THE EXACT TIMING OF THAT FAILURE. THE REVISION SURGERY TOOK PLACE APPROXIMATELY 7 WEEKS AFTER THE INITIAL SURGERY (IMPLANT DATE: (B)(6) 2024, EXPLANT DATE: (B)(6) 2024). THE REP REPORTED, "I CANNOT ANSWER IF THE PATIENTS WAS COMPLAINING. I DO NOT KNOW THE ANSWER. I DO NOT KNOW THE OUTCOME OF THE REVISION LONG TERM, BUT THE INFORMATION IS THAT THE REVISION WAS COMPLETED SUCCESSFULLY BUT NOT SURE IF THAT WAS WITH ACCELUS PRODUCT OR NOT." THE FAILED PRODUCT WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions; Vertebral Fracture
MAUDE report 19951030 ↗InjuryApr 11, 2022Migration or Expulsion of Device; Migration or Expulsion of Device
ON 03FEB22 ACCELUS WAS INFORMED OF A COMPLAINT ON A LINESIDER NON-MODULAR STANDARD SCREW. IT WAS ORIGINALLY REPORTED BY THE REP THAT AN INTRAOPERATIVE SCREW HEAD SEPARATION HAD OCCURRED DURING THE PROCEDURE. AT THE TIME, THIS WAS ALL THE INFORMATION THAT WAS AVAILABLE. NEW INFORMATION WAS RECEIVED ON 11MAR22. PER THE COMPLAINT ENTRY FORM RECEIVED ON 11MAR22, THE REPORTED WELD FAILURE OCCURRED DURING A REVISION PROCEDURE. THE INITIAL SURGERY WAS A 4 LEVEL PLIF AND FIXATION PROCEDURE THAT TOOK PLACE ON (B)(6) 2021. DURING A POSTOPERATIVE FOLLOW UP VISIT IT WAS NOTED THAT ONE OF CEPHALAD SCREWS WAS LOOSENING, AS A RESULT, THE SURGEON OPTED TO REVISE THE PROCEDURE. THE REVISION PROCEDURE TOOK PLACE ON (B)(6) 2022. IT WAS NOTED DURING THE REVISION PROCEDURE THAT ONE OF THE CAUDAL SCREWS HAD A SEPARATED TULIP HEAD. IT IS UNKNOWN IF THIS SEPARATION OCCURRED POSTOPERATIVELY OR DURING THE REVISION PROCEDURE. THE PROCEDURE WAS COMPLETED BY REMOVING AND REPLACING THE LOOSE CEPHALAD SCREW AND THE SEPARATED CAUDAL SCREW. THE REPORTED WELD FAILURE RESULTED IN A 10 MINUTE DELAY TO THE REVISION PROCEDURE. NO ADDITIONAL PATIENT HARM WAS REPORTED AS A RESULT OF THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14074144 ↗InjuryMar 2, 2022Fracture; Fracture
ON (B)(6) 2022 ACCELUS WAS INFORMED OF A FAILURE ON A NON-MODULAR MIS TULIP SCREW (PART: LS-N6MG7545). THE SURGEON AT THE SPECIALTY HOSPITAL OF SHREVEPORT WAS PERFORMING A TWO LEVEL ALIF AND FIXATION PROCEDURE ON (B)(6) 2022. THE FAILURE WAS NOTED BY THE SURGEON'S PA WHILE THEY WERE REVIEWING POSTOP FILMS PRIOR TO DISCHARGING THE PATIENT. FURTHER DISCUSSION WITH THE SURGEON CONFIRMED THAT THE FAILURE OCCURRED INTRAOPERATIVELY AND WENT UNNOTICED AT THE TIME OF THE PROCEDURE. FILM IMAGES CONFIRMED A SCREW HEAD SEPARATION AT THE L4 SEGMENT. THE PATIENT WAS NOT DISCHARGED, AND A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO REMOVE AND REPLACE THE IMPACTED SCREW. THE PATIENT IS REPORTEDLY DOING FINE WITH NO FURTHER ISSUES OR COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13656845 ↗MalfunctionFeb 18, 2022Fracture; Fracture
ON 27JAN2022 ACCELUS WAS INFORMED OF A POST OPERATIVE FAILURE ON A NON-MODULAR STANDARD SCREW. THE ORIGINAL PROCEDURE WAS PERFORMED ON (B)(6) 2021. DURING A 6 WEEK FOLLOW UP VISIT IT WAS CONFIRMED BY X-RAY IMAGING THAT ONE OF THE TULIPS WAS DISSOCIATED FROM THE SCREW SHANK. ACCELUS WAS ADVISED THAT THE SCREW HEAD APPEARS IN IMAGING TO HAVE BROKEN AT THE POINT WHERE IT ATTACHES TO THE SHAFT (OR TULIP WAS DISSOCIATED FROM THE SCREW) AND THIS MAY BE CONSISTENT WITH A POTENTIAL WELD FAILURE THOUGH INVESTIGATION IS STILL UNDERWAY. THE PATIENT IS CURRENTLY ASYMPTOMATIC, AT THIS TIME THERE ARE NO PLANS TO PERFORM A REVISION SURGERY. THE SURGEON INTENDS TO MONITOR THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13559965 ↗MalfunctionJan 7, 2022Fracture; Fracture
ON 08-DEC-2021 ACCELUS WAS INFORMED OF A POST-OPERATIVE FAILURE ON A NON-MODULAR STANDARD SCREW. ACCELUS WAS ADVISED THAT THE SCREW HEAD APPEARS IN IMAGING TO HAVE BROKEN AT THE POINT WHERE IT ATTACHES TO THE SHAFT (OR TULIP WAS DISSOCIATED FROM THE SCREW) AND THIS MAY BE CONSISTENT WITH A POTENTIAL WELD FAILURE THOUGH INVESTIGATION IS STILL UNDERWAY. THE ORIGINAL PROCEDURE WAS A 2 LEVEL TLIF AND FIXATION PROCEDURE AND TOOK PLACE ON (B)(6) 2021. CURRENTLY THERE ARE NO PLANS TO PERFORM A REVISION SURGERY AS THE PATIENT IS DOING WELL AND HEALING AS EXPECTED. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13196810 ↗InjuryJun 4, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL POSTERIOR FIXATION PROCEDURE ON (B)(6) 2021. SUBSEQUENTLY, POST-OPERATIVE IMAGES, OBTAINED ON (B)(6) 2021, REVEALED DISSOCIATION OF THE LINESIDER STANDARD TULIP FROM THE SCREW SHANK. A REVISION PROCEDURE WAS CONDUCTED ON (B)(6) 2021.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11943051 ↗InjuryApr 28, 2021Migration; Migration
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL ONE-LEVEL POSTERIOR FIXATION PROCEDURE ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO POSTERIOR PULL-OUT OF THE L4 PEDICLE SCREW AWAY FROM THE BONE, POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11737903 ↗InjuryApr 7, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TWO-LEVEL FIXATION PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED THREE DAYS LATER DUE TO DISSOCIATION OF THE SET SCREW FROM THE PEDICLE SCREW ASSEMBLY. DURING THE REVISION PROCEDURE, AS THE SURGEON ATTEMPTED TO PLACE A NEW SET SCREW, IT WAS IDENTIFIED THAT THE THREADS ON THE TULIP OF THE ASSEMBLY WERE DAMAGED. AS A RESULT, HE OPTED TO REVISE THE ENTIRE PEDICLE SCREW CONSTRUCT ALONG THE IPSILATERAL SIDE. THE NEW ASSEMBLIES AND SET SCREWS WERE PLACED WITH NO ISSUE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11627587 ↗MalfunctionAug 24, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THAT NO SERIOUS INJURY WAS REPORTED AS A RESULT OF THIS PRODUCT MALFUNCTION. ADDITIONALLY, THIS MALFUNCTION HAS NOT PREVIOUSLY BEEN REPORTED TO INTEGRITY IMPLANTS AS HAVING CAUSED OR CONTRIBUTED TO A SERIOUS INJURY ON A SAME/SIMILAR DEVICE IN THE PAST. THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED.
Patient problems: Foreign Body In Patient
MAUDE report 10444571 ↗
Other Integrity Implants Inc. products
All Integrity Implants 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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