TiLock 1 (REF G711-65-45)Recalls & reported problems
Genesys Orthopedics Systems LLC · Break-Off Pedicle Screw · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M719G71165450), received between Aug 8, 2024 and Aug 8, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Use of Device Problem” (1 report).
1 other recall cover devices cleared under the same FDA submission (K100757); they may or may not involve this specific model.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Use of Device Problem1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 8, 2024Use of Device Problem; Use of Device Problem
A DISTRIBUTOR INFORMED GENESYS SPINE THAT DR. (B)(6) DISCOVERED ON X-RAY A BROKEN 6.5MM DIAMETER TILOCK2 PEDICLE SCREW (ORIGINALLY IMPLANTED IN 2020 OR 2021, L4 TO S1 FUSION) WHEN DOING A PLANNED IMPLANT OF ADDITIONAL ADJACENT SCREWS. REVISION OF THE BROKEN SCREW HEAD AND SCREW TOOK PLACE DURING THE SAME DAY. THE SCREW BODY WAS MISPLACED BUT THE SCREW HEAD WAS RETURNED THE WEEK OF (B)(6) 2024. NO PATIENT SYMPTOMS OR COMPLAINTS WERE NOTED THAT INDICATED A BROKEN SCREW PRIOR TO THE X-RAY IDENTIFICATION. DISTRIBUTOR INDICATED THAT THE BROKEN SCREW WAS ONLY REMOVED BECAUSE OF INTERFERENCE WITH THE PLANNED IMPLANTS. BONY FUSION HAD BEEN ACHIEVED AT L4-S1 PRIOR TO THE SCREW FRACTURE. ACCORDING TO GENESYS SPINE VP OF FIELD SERVICES, THE SCREW CHOSEN AT IMPLANT MAY BE UNDERSIZED FOR THE INTENDED LOCATION AND APPLICATION, AND IDEALLY WOULD HAVE BEEN EITHER A 7.5MM OR 8.5MM SCREW.
Patient problems: Failure of Implant
MAUDE report 19939325 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K100757. One submission often covers many models, so check the product and lot details in each record.
- Z-2677-2014 · Apr 2, 2014 · TerminatedCircular Lock Screws, part # G826, lot # 11406. The Lock Screws are part of the Genesys Spine TiLock Pedicle Screw System. The TiLock Pedicle Screw System is intended to provide i
Other Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease devices
- EXPEDIUM VERSE 199721000Medos International Sàrl · Orthosis, spinal pedicle fixation, for degenerative disc disease387 reports
- Sequoia® 3301-1Zimmer Spine, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease184 reports
- CD HORIZON® Spinal System 8590855Medtronic Sofamor Danek, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease179 reports
- Vitality® 07.02011.001Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease3 recalls0 reports
- EXPEDIUM VERSE 199721001SMedos International Sàrl · Thoracolumbosacral pedicle screw system124 reports
- LineSider LS-N6SA7550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls1 report
- LineSider LS-N6SA6545Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls0 reports
- EXPEDIUM VERSE 199721000SMedos International Sàrl · Thoracolumbosacral pedicle screw system97 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.