Capstone Control PTC Spinal System 5001027Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SPACER 5001027 CONTROL PTC 6 DEG 10X27 · Class 2 · Implant
All models of Capstone Control PTC Spinal System (12)
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 00643169679832), received between Sep 3, 2019 and Sep 3, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Migration” (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
- Migration1
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.
MalfunctionSep 3, 2019Migration; Migration
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
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8954883 ↗
Other Intervertebral fusion device with bone graft, lumbar devices
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- Catalyft PL Expandable Interbody System 6069076Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall51 reports
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- 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 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.
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