Capstone Control PTC Spinal System 5021522Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SPACER 5021522 CONTROL PTC 18 DEG 15X22 · 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 00643169677739), received between Oct 5, 2019 and Oct 5, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Migration or Expulsion 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
- Migration or Expulsion of Device1
Patient problems
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 5, 2019Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT CAGE REPLACEMENT SURGERY AT L5-S1. THE ALLEGED IMPLANT (SPACER) WAS IMPLANTED IN THIS SURGERY. ON AN UNKNOWN DATE, POST-OP, SINKING OF THE CAGE AND LOOSENING OF THE SERRATO SCREW WAS REPORTED. THERE WAS ALSO A SUSPICION OF INFECTION AT L5-S1. HENCE, THE PATIENT UNDERWENT A REVISION SURGERY, IN WHICH THE ALLEGED SPACER WAS EXPLANTED, SCREW REPLACEMENT WAS PERFORMED, AND AUTOGENOUS BONE GRAFT WAS INSERTED AT L5-S1. THERE WAS A DELAY OF MORE THAN 60 MINUTES IN OVERALL PROCEDURE TIME AS A RESULT OF THIS EVENT. ALTHOUGH REMOVAL OF THE SPACER WAS DIFFICULT AND TOOK TIME, IT WAS REMOVED SUCCESSFULLY. PATIENT OUTCOME IS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 9160081 ↗
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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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