Shoreline ACS 86-0011Recalls & reported problems
Seaspine Orthopedics Corporation · Inserter With Stop · Class 1
All models of Shoreline ACS (16)
Data updated Oct 18, 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 10889981137472), received between Jun 3, 2026 and Jun 3, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 3, 2026Fracture
ON (B)(6) 2026, ORTHOFIX BECAME AWARE OF A REPORT INVOLVING A SHORELINE INSERTER THAT FRACTURED DURING A SPINAL FUSION PROCEDURE WHILE IN CONTACT WITH THE PATIENT. IT WAS REPORTED THAT THE THREADED PORTION OF THE INSERTER FRACTURED AND REMAINED WITHIN AN IMPLANTED ORTHOFIX WAVEFORM C INTERBODY DEVICE. THE PROCEDURE WAS DELAYED APPROXIMATELY 5-7 MINUTES. THE PROCEDURE WAS COMPLETED WITH THE FRACTURED THREADED PORTION REMAINING WITHIN THE WAVEFORM C INTERBODY DEVICE AND A NON-ORTHOFIX PLATE IMPLANTED OVER THE INTERBODY. NO PATIENT INJURY, DEATH, OR ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25375208 ↗
Other SCREWDRIVER devices
- DELTA XTEND 2307-92-003Depuy (Ireland) · SCREWDRIVER751 reports
- EXPEDIUM 279712400Medos International Sàrl · SCREWDRIVER551 reports
- NA 314.467Synthes GmbH · SCREWDRIVER498 reports
- N/A 5584111Medtronic Sofamor Danek, Inc. · SCREWDRIVER492 reports
- QUICKSET 2274-47-000Depuy (Ireland) · SCREWDRIVER487 reports
- NA 03.130.010Synthes GmbH · SCREWDRIVER1 recall422 reports
- QUICKSET 2274-63-000Depuy (Ireland) · SCREWDRIVER404 reports
- EVOS 71175072Smith & Nephew, Inc. · SCREWDRIVER336 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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