Capstone Control PTC Spinal System 5021527Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SPACER 5021527 CONTROL PTC 18 DEG 15X27 · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169677678), received between Apr 30, 2019 and Apr 30, 2019 — classified as 1 injury.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.
InjuryApr 30, 2019Malposition of Device; Malposition of Device
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH DEGENERATIVE KYPHOSCOLIOSIS; AND UNDERWENT POSTEROLATERAL SPINAL FUSION AT T9-S2AI A ND POSTERIOR LUMBAR INTERBODY FUSION AT L4-L5. INTRA-OP, AT THE TIME OF PERFORMING PLIF AT L4/5, WHEN THE PHYSICIAN TRIED TO PLACE THE IMPLANT, IT DROPPED TO THE ANTERIOR DIRECTION. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN THE OVERALL PROCEDURE TIME DUE TO THIS EVENT; HOWEVER, NO PATIENT COMPLICATIONS WERE REPORTED. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2019, WHEREIN THE MALPOSITIONED IMPLANT WAS REMOVED SUCCESSFULLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8564507 ↗
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 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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