REFLECT 1244.1351SRecalls & reported problems
Globus Medical, Inc. · REFLECT 5.0mm Cord with Collet, 350mm · Class N
Data updated Oct 18, 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 00193982313470), received between May 28, 2025 and May 28, 2025 — classified as 1 injury.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A REVISION WAS NEEDED TO REMOVE THE COLLET AND EXCESS CORD FROM THE REFLECT IMPLANT THAT WAS NOT REMOVED DURING THE ORIGINAL SURGERY, CONFIRMED BY POST OP SCANS.
Patient problems: Insufficient Information
MAUDE report 22099883 ↗
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- The Tether™ 211H6032Zimmer Biomet Inc · Vertebral Body Tethering System6 reports
- The Tether™ 211H6030Zimmer Biomet Inc · Vertebral Body Tethering System4 reports
- The Tether™ 211H6035Zimmer Biomet Inc · Vertebral Body Tethering System3 reports
- The Tether™ 211H7040Zimmer Biomet Inc · Vertebral Body Tethering System2 reports
- The Tether™ 211H7035Zimmer Biomet Inc · Vertebral Body Tethering System2 reports
- The Tether™ 211H7037Zimmer Biomet Inc · Vertebral Body Tethering System2 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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