CONCORDE® ProTi 360°™ 188823107Recalls & reported problems
Tyber Medical, LLC · Class 2 · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00819917020748), received between Jan 20, 2023 and Oct 23, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information1
- Migration or Expulsion of Device1
Patient problems
- Arthritis1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 23, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THIS WAS A TLIF (L4/5) PERFORMED ON (B)(6) 2023. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER SURGERY, ASD OCCURRED. A REVISION SURGERY TO EXTEND FIXATION IS SCHEDULED FOR (B)(6) 2023. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 17987725 ↗InjuryJan 20, 2023Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED THAT THIS WAS A TLIF FOR THE SPINAL STENOSIS ON (B)(6) 2022. ALTHOUGH THE CAGE HAS BEEN INSERTED IN PROPER POSITION, THE CAGE BACKED OUT BACKWARDS AFTER THE PRIMARY SURGERY. THEREFORE, A REVISION SURGERY WILL BE PERFORMED ON (B)(6) 2023. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE
Patient problems: Arthritis
MAUDE report 16215490 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.