eXpress® 139-15-1414-SRecalls & reported problems
Novastep · Compressive staple 15-14-14 · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 03700879502328), received between Jun 26, 2019 and Jun 26, 2019 — classified as 2 injuries.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (2 reports).
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
- Material Split, Cut or Torn2
Patient problems
- No Code Available1
- No Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 26, 2019Material Split, Cut or Torn; Material Split, Cut or Torn
TWO STAPLES (139-15-1414-S, LOT NUMBER 170005 / 180011), WERE IMPLANTED ON (B)(6) 2019 FOR A RADIOLUNATE FUSION. BOTH STAPLES BROKE IN THE PATIENT ON (B)(6) 2019. THE REVISION SURGERY WAS PERFORMED ON THE PATIENT ON (B)(6) 2019. BOTH BROKEN STAPLES WERE RETURNED TO EXTREMITY MEDICAL FOR ANALYSIS.
Patient problems: No Information
MAUDE report 8733756 ↗InjuryJun 26, 2019Material Split, Cut or Torn; Material Split, Cut or Torn
DESCRIPTION: TWO STAPLES (139-15-1414-S, LOT NUMBERS 170005 / 180011 ) WERE IMPLANTED ON (B)(6) 2019 FOR A RADIOLUNATE FUSION. BOTH STAPLES BROKE IN THE PATIENT ON (B)(6) 2019. THE REVISION SURGERY WAS PERFORMED ON THE PATIENT, ON (B)(6) 2019. BOTH BROKEN STAPLES WERE RETURNED TO EXTREMITY MEDICAL FOR ANALYSIS.
Patient problems: No Code Available
MAUDE report 8733750 ↗
Other Staple, Fixation, Bone devices
- N/A StandardSynthes GmbH · Staple, Fixation, Bone2 recalls16 reports
- GII QUICKANCHOR ETHIBOND 212034Medos International Sàrl · STAPLE, FIXATION, BONE98 reports
- GII QUICKANCHOR ORTHOCORD 222983Medos International Sàrl · STAPLE, FIXATION, BONE94 reports
- Speed SE-0910Synthes GmbH · Staple, Fixation, Bone1 recall24 reports
- Speed Shift SE-2020-10Synthes GmbH · Staple, Fixation, Bone1 recall10 reports
- Lapiplasty SpeedPlate SK50Treace Medical Concepts, Inc. · Staple, Fixation, Bone59 reports
- Speed SE-1512Synthes GmbH · Staple, Fixation, Bone1 recall6 reports
- LUPINE ORTHOCORD 210709Depuy Mitek, LLC · STAPLE, FIXATION, BONE56 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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