CAPSTONE® Spinal System 2990722Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SPACER 2990722 CAPSTONE PEEK 07X22 · Class 2 · Implant
Data updated Oct 13, 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 00613994387295), received between Jun 21, 2018 and Jun 21, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Malposition of Device” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Malposition of Device1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 21, 2018Malposition of Device; Malposition of Device
IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR FUSION AT TH9-S2AI DUE TO SCOLIOSIS. INTRA-OP, WHILE PERFORMING POSTERIOR LUMBAR INTERBODY FUSION BETWEEN L5/S, THE CAGE WAS DEEPLY INSERTED IN THE INTERVERTEBRAL DISC SPACE AND IT WAS IN THE STATE OF BACKING OUT IN ANTERIOR OF THE VERTEBRAL BODY, AS CONFIRMED LATER WITH THE IMAGE. THE DOCTOR JUDGED THAT THERE WAS NO INJURY TO THE BLOOD VESSEL ETC., AND THE CAGE WAS INDWELT IN THE PATIENT¿S BODY WITHOUT BEING REMOVED; A CAGE OF A BIGGER SIZE WAS INSTALLED INSTEAD. THE ENTRANCE OF THE INTERVERTEBRAL SPACE WAS NARROW AND THE INNER PART BECAME WIDENED SLIGHTLY. PATIENT COMPLICATIONS WERE REPORTED AS UNKNOWN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7624858 ↗
Other Intervertebral fusion device with bone graft, lumbar devices
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- Catalyft PL Expandable Interbody System 6068073Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall66 reports
- Catalyft PL Expandable Interbody System 6069076Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall51 reports
- Catalyft PL Expandable Interbody System 6068076Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall46 reports
- EIT TLIF Inserter TFT30101EIT Emerging Implant Technologies GmbH · Intervertebral Fusion Device With Bone Graft, Lumbar88 reports
- T-PAL 03.812.001Synthes GmbH · Intervertebral fusion device with bone graft, lumbar76 reports
- Catalyft PL Expandable Interbody System 6069096Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall25 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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