Capstone Control PTC Spinal System 5011227Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SPACER 5011227 CONTROL PTC 12 DEG 12X27 · 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 00643169677593), received between Jun 24, 2018 and Jun 24, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
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 24, 2018Break; Break
DATE OF INITIAL SURGERY: (B)(6) 2018. TYPE AND LEVEL OF INITIAL SURGERY: L5- S1 TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF). PRE-OPERATIVE DIAGNOSIS: COMPRESSION OF THE NERVE. IT WAS REPORTED THAT INTRA-OPERATIVELY THE SPACER WAS BROKEN WHILE PERFORMING ROTATION. THE THREAD WAS BROKEN AND UNABLE TO ATTACHED AGAIN. THE DEVICE COME IN CONTACT WITH THE PATIENT. PROCEDURE WAS COMPLETED WITH ANOTHER NEW CAGE. PATIENT COMPLICATIONS WERE UNKNOWN WITH THE AVAILABLE INFORMATION. THE PRODUCT WAS INSERTED INTO THE INTERVERTEBRAL SPACE AND ROTATION WAS PERFORMED. THE THREAD WAS BROKEN AND UNABLE TO GRIPPED. THE NEW CAGE WAS OPENED TO COMPLETE THE PROCEDURE. THE TIP OF INSERTER BECOME WIDENED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7632773 ↗
Other Intervertebral fusion device with bone graft, lumbar devices
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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 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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