Capstone Control PTC Spinal System 5011327Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SPACER 5011327 CONTROL PTC 12 DEG 13X27 · 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 00643169677609), received between Jun 17, 2019 and Jun 17, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Deformation” (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
- Material Deformation1
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 17, 2019Material Deformation; Material Deformation
IT WAS REPORTED THAT THE PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L5-S1 DUE TO LUMBAR CANAL STENOSIS. INTRA-OP, AFTER THE CAGE WAS INSERTED AND ROTATED, THE PHYSICIAN REMOVED THE INSERTER TO CHECK, AND IT WAS FOUND THAT THE CAGE WAS ROTATED TOO MUCH. THEN, WHILE TRYING TO ROTATE THE CAGE BACK, THE CAGE COULD NOT BE GRIPPED WITH THE INSERTER AGAIN. THE CAGE WAS THEN REMOVED WITH A HOSPITAL OWNED INSTRUMENT; AND IT WAS FOUND THAT THE THREADED PART OF THE CAGE WAS STRIPPED. HENCE, A NEW CAGE WAS INSERTED IN ITS PLACE. THERE WAS A DELAY OF LESS THAN 60 MINUTES DUE TO THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED. DOCTOR ADMITTED HIS MISTAKE FOR HAVING THE CAGE OVER-INSERTED FORCIBLY IN A PLACE WHERE THE INTERVERTEBRAL DISC SPACE WAS NARROW.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8705033 ↗
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
- 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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