ENDOSKELETON® TAS nanoLOCK® Surface Technology 2307-0212-NRecalls & reported problems
Medtronic Sofamor Danek, Inc. · Interbody Fusion Device 7 Degree Large 12mm · Class 2 · Implant
All models of ENDOSKELETON TAS nanoLOCK Surface Technology (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 00191375013853), received between Aug 16, 2017 and Aug 16, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).
4 other recalls cover devices cleared under the same FDA submission (K141953, K173535, K183557, K192018); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Device Dislodged or Dislocated1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 16, 2017Device Dislodged or Dislocated
A REVISION FROM AN ENDOSKELETON® TAS CASE FROM (B)(6)2017 WAS PERFORMED ON (B)(6)2017. THE REVISION WAS SCHEDULED AS IT WAS DETERMINED THE IMPLANT SUBSIDED INTO THE VERTEBRAL BODY ON L3-L4. THE SURGEONS INVOLVED IN THE ORIGINAL CASE AND THE REVISION CASE CONCUR THAT THE IMPLANT DID NOT RESULT IN THE FAILURE AS THE PATIENT HAD UNUSUALLY SOFT BONE.
Patient problems: No Code Available
MAUDE report 6799175 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K141953, K173535, K183557, K192018. One submission often covers many models, so check the product and lot details in each record.
- Z-0085-2022 · Sep 2, 2021 · TerminatedEndoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, Nanolock 12 Dg Interbody, Large, 12mm
- Z-0086-2022 · Sep 2, 2021 · TerminatedEndoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm
- Z-1439-2021 · Mar 17, 2021 · TerminatedEndoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Small, 8 mm, Product Number 5146-1208-N - Product Usage: indicated to be used with supplemental f
- Z-1440-2021 · Mar 17, 2021 · TerminatedEndoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Large, 8 mm, Product Number 5146-1608-N - Product Usage: indicated to be used with supplemental f
Other Intervertebral fusion device with integrated fixation, lumbar devices
- PIVOX™ Oblique Lateral Spinal System 2161001Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with integrated fixation, lumbar182 reports
- IdentiTi 232-10-85-300Alphatec Spine, Inc. · Intervertebral fusion device with integrated fixation, lumbar1 recall8 reports
- IdentiTi 232-10-85-250Alphatec Spine, Inc. · Intervertebral fusion device with integrated fixation, lumbar1 recall5 reports
- IdentiTi 132-10-85-300Alphatec Spine, Inc. · Intervertebral fusion device with integrated fixation, lumbar1 recall3 reports
- MectaLIF Anterior 03.30.301Medacta International SA · Intervertebral Fusion Device With Integrated Fixation, Lumbar1 recall2 reports
- IdentiTi 232-10-85-350Alphatec Spine, Inc. · Intervertebral fusion device with integrated fixation, lumbar1 recall2 reports
- IdentiTi 232-11-90-350Alphatec Spine, Inc. · Intervertebral fusion device with integrated fixation, lumbar1 recall1 report
- MectaLIF Anterior 03.30.302Medacta International SA · Intervertebral Fusion Device With Integrated Fixation, Lumbar1 recall1 report
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 18, 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