Apache 1 (REF GT-09-SL)Recalls & reported problems
Genesys Orthopedics Systems LLC · SMALL TLIF-LORDOTIC · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M719GT09SL0), received between Oct 24, 2016 and Oct 24, 2016 — classified as 1 malfunction.
The most frequently reported specific device problem is “Disassembly” (1 report).
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.
Most reported problems
Device problems
- Disassembly1
- Failure To Adhere Or Bond1
- Misconnection1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 24, 2016Failure To Adhere Or Bond; Disassembly; Misconnection; Failure To Adhere Or Bond; Disassembly; Misconnection
DUE TO A MALFUNCTION WITH THE IMPLANT'S INSERTER A SMALL PIECE OF A PEEK INTERBODY CHIPPED OFF WHILE THE INTERBODY WAS BEING ADVANCED INTO THE DISK SPACE. THIS PIECE WAS RETRIEVED WITHOUT INCIDENT AND WITHOUT ANY ACUTE IMPACT TO THE PATIENT. THE PATIENT IS PROCEEDING WITH A NORMAL POST-OP RECOVERY FOLLOWING THE SURGEON'S STANDARD TREATMENT REGIMEN. THE INTERBODY WAS A TLIF.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6051602 ↗
Other Spinal Vertebral Body Replacement Device devices
- X-CORE 7180018Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- X-CORE 7220018Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- GIZA Corpectomy implant Giza, Diam 14 mm, 18-22 mm, 5-8 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
- GIZA Corpectomy implant Giza, Diam 14 mm, 23-32 mm, 7-10 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
- X-CORE 7160012Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- GIZA Corpectomy implant Giza, Diam 14 mm, 23-32 mm, 2-5 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
- X-CORE 7180016Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- X-CORE 7160014Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 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