Shoreline ACSRecalls & reported problems across all models
Seaspine Orthopedics Corporation · 16 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 30
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls
- 0
We found 16 models of Shoreline ACS by Seaspine Orthopedics Corporation in the FDA's device registry (GUDID). Together they are named in 30 adverse event reports in the FDA's MAUDE database, received between Aug 24, 2021 and Sep 21, 2026 — classified as 10 injuries, 20 malfunctions.
The most frequently reported specific device problem is “Fracture” (12 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Shoreline ACS problems
Device problems
- Fracture12
- Migration4
- Separation Failure3
- Accessory Incompatible2
- Off-Label Use2
- Premature Separation2
- Adverse Event Without Identified Device or Use Problem1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- No Clinical Signs, Symptoms or Conditions20
- Insufficient Information6
- Foreign Body In Patient4
- Neck Pain1
- Numbness1
- Pain1
- Unspecified Nervous System Problem1
Shoreline ACS models
16 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Shoreline ACS 86-0010Intervertebral fusion device with integrated fixation, cervical8 reports
- Shoreline ACS 85-2107Intervertebral fusion device with integrated fixation, cervical4 reports
- Shoreline ACS 85-2006Intervertebral fusion device with integrated fixation, cervical3 reports
- Shoreline ACS 85-1407-SIntervertebral fusion device with integrated fixation, cervical2 reports
- Shoreline ACS 85-3016Intervertebral fusion device with integrated fixation, cervical2 reports
- Shoreline ACS 85-0206-SIntervertebral fusion device with integrated fixation, cervical1 report
- Shoreline™ ACS 85-0810-SIntervertebral fusion device with integrated fixation, cervical1 report
- Shoreline ACS 85-1709-SIntervertebral fusion device with integrated fixation, cervical1 report
- Shoreline ACS 85-2008Intervertebral fusion device with integrated fixation, cervical1 report
- Shoreline ACS 85-2106Intervertebral fusion device with integrated fixation, cervical1 report
- Shoreline ACS 85-2108Intervertebral fusion device with integrated fixation, cervical1 report
- Shoreline ACS 85-3214Intervertebral fusion device with integrated fixation, cervical1 report
- Shoreline ACS 85-4018Intervertebral fusion device with integrated fixation, cervical1 report
- Shoreline ACS 86-1000Intervertebral fusion device with integrated fixation, cervical1 report
- Shoreline ACS 86-0011SCREWDRIVER1 report
- Shoreline ACS 86-0013Intervertebral fusion device with integrated fixation, cervical1 report
Recent Shoreline ACS adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 21, 2026Accessory Incompatible
Patient problems: Insufficient Information
MAUDE report 50846941 ↗InjurySep 11, 2026Migration
Patient problems: Insufficient Information
MAUDE report 50742615 ↗InjurySep 9, 2026Fracture
Orthofix was made aware on 12 AUG 2026 that a patient underwent spinal surgery consisting of the Shoreline ACS system. The index surgery occurred on (b)(6) 2026. It was reported that an 85-2107 7mm, Locking Cover fractured into the interbody intra-operatively and the threaded portion was left in the interbody. The fracture occurred when the surgeon tried to advance the 85-2107 7mm, Locking Cover using the Locking Handle. According to the reporter, the 85-2107 7mm, Locking Cover did not advance and was not seated properly. Since the interbody was already fixated at C6-7 with the screws, the surgeon elected to leave the construct in place and not remove the fractured threaded portion of the Locking Cover. No patient injuries or additional medical intervention were reported. Per the reporter, the patient is recovering well.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50693454 ↗InjuryAug 5, 2026Fracture
On 06 JUL 2026 Orthofix received a report involving a Shoreline Inserter that fractured while inserting the cage. Customer confirmed on (b)(6) 2026 that both the fractured fragment and the cage remained in the patient. It was reported that the patient is doing well and entered the MRI scanner without any issues. The physician informed the reporter that the patient is fine and expressed no concerns regarding the incident.
Patient problems: Foreign Body In Patient
MAUDE report 50145684 ↗MalfunctionJun 15, 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 INSERTER FRACTURED AND A FRAGMENT REMAINED IMPLANTED. THE PROCEDURE WAS DELAYED APPROXIMATELY 10 MINUTES. THE PROCEDURE WAS COMPLETED WITH THE FRAGMENT REMAINING WITHIN THE IMPLANT AND AN ADMIRAL PLATE IMPLANTED OVER THE INTERBODY. NO PATIENT INJURY, DEATH, OR ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 25510737 ↗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 ↗MalfunctionMar 6, 2026Fracture
SEASPINE/ORTHOFIX BECAME AWARE ON 05 FEB 2026 THAT THE TIP OF A SHORELINE ACS INSERTER FRACTURED INTRA-OPERATIVELY WHEN INSERTING THE WAVEFORM C INTERBODY. THE FRACTURED TIP COULD NOT BE RETRIEVED FROM THE INTERBODY AND WAS LEFT IN-SITU. AS A RESULT, THE LOCKING COVER WAS UNABLE TO BE ADDED TO THE CONSTRUCT. AS THE SURGERY WAS COMPLETED WITHOUT THE LOCKING COVER, ORTHOFIX/SEASPINE CANNOT GUARANTEE THE STABILITY OF THE CONSTRUCT POST-OPERATIVELY. NO PATIENT INJURIES WERE REPORTED.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 24533727 ↗MalfunctionMar 2, 2026Separation Problem
ORTHOFIX WAS MADE AWARE ON 03 FEB 2026 THAT A WAVEFORM C NO-PROFILE INTERBODY DEVICE LOCKING COVER WAS OBSERVED TO HAVE LOOSENED/BACKED OUT APPROXIMATELY SIX (6) WEEKS POSTOPERATIVELY. THE INDEX SURGERY OCCURRED ON (B)(6) 2025. THE SURGEON REPORTED THAT INTRAOPERATIVE FLUOROSCOPIC IMAGING (C-ARM) CONFIRMED THE LOCKING COVER WAS FLUSH AND FULLY SEATED AT THE TIME OF IMPLANTATION. AT APPROXIMATELY SIX WEEKS POSTOPERATIVELY, FOLLOW-UP IMAGING DEMONSTRATED THAT THE LOCKING COVER HAD MIGRATED/BACKED OUT FROM ITS ORIGINAL SEATED POSITION.
Patient problems: Insufficient Information
MAUDE report 24488463 ↗MalfunctionNov 11, 2025Off-Label Use; Off-Label Use
SEASPINE/ORTHOFIX BECAME AWARE ON 16 OCT 2025 THAT THE TIP OF A SHORELINE ACS INSERTER FRACTURED INTRA-OPERATIVELY WHEN INSERTING THE WAVEFORM C INTERBODY. THE DISTRIBUTOR REP REPORTED THAT ALL OF THE FRACTURED PIECES WERE RETRIEVED, HOWEVER, THE LOCKING COVER WAS UNABLE TO BE ADDED TO THE CONSTRUCT. AS THE SURGERY WAS COMPLETED WITHOUT THE LOCKING COVER, ORTHOFIX/SEASPINE CANNOT GUARANTEE THE STABILITY OF THE CONSTRUCT POST-OPERATIVELY; THEREFORE, BASED ON THIS RISK CHARACTERIZATION, THE EVENT WAS DETERMINED TO BE REPORTABLE. NO PATIENT INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23523333 ↗MalfunctionNov 7, 2025Material Fragmentation; Material Fragmentation
A PATIENT UNDERWENT SPINAL SURGERY ON (B)(6) 2025 UTILIZING THE SEASPINE/ORTHOFIX SHORELINE ACS SYSTEM. DURING THE SURGERY, THE SHORELINE ACS LOCKING COVER BROKE. THE PLATE WAS REPLACED WITH AN ALTERNATE, HOWEVER, THE REP STATES A PIECE OF THE BROKEN LOCKING COVER WAS LEFT IN-SITU. THE SURGERY WAS ABLE TO BE COMPLETED AND NO PATIENT INJURY OR SIGNIFICANT CLINICAL DELAY WAS REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 23502504 ↗InjuryOct 20, 2025Accessory Incompatible; Accessory Incompatible
A PATIENT UNDERWENT SPINAL SURGERY ON (B)(6) 2025 UTILIZING THE SEASPINE/ORTHOFIX SHORELINE ACS SYSTEM. SEASPINE/ORTHOFIX BECAME AWARE ON 23 SEP 2025 THAT A REVISION SURGERY OCCURRED AS A RESULT OF THE INABILITY TO APPLY THE INTERBODY LOCKING MECHANISM, RENDERING THE CONSTRUCT POTENTIALLY UNSTABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23342658 ↗MalfunctionJul 15, 2025Migration; Migration
A PATIENT UNDERWENT ANTERIOR CERVICAL DISCECTOMY FUSION (ACDF) SPINE SURGERY ON (B)(6) 2025 UTILIZING SEASPINE/ORTHOFIX'S WAVEFORM C AND SHORELINE ACS SYSTEMS. ON (B)(6) 2025, SEASPINE/ORTHOFIX WAS NOTIFIED THAT THE SHORELINE ACS NO-PROFILE LOCKING COVER HAD PREMATURELY DISENGAGED FROM THE WAVEFORM C NO-PROFILE INTERBODY CONSTRUCT.
Patient problems: Insufficient Information
MAUDE report 22507315 ↗MalfunctionJun 9, 2025Premature Separation; Premature Separation
A PATIENT UNDERWENT ANTERIOR CERVICAL DISCECTOMY FUSION (ACDF) SPINAL SURGERY ON (B)(6) 2025. ON (B)(6) 2025, IT WAS OBSERVED DURING ROUTINE POSTOPERATIVE FOLLOW UP THAT THE NO PROFILE LOCKING COVER SEPARATED FROM THE NO PROFILE SPACER.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22168864 ↗MalfunctionMay 15, 2025Fracture; Fracture
ON (B)(6) 2025, A PATIENT UNDERWENT SPINAL SURGERY CONSISTING OF SHORELINE ACS AND WAVEFORM C SYSTEMS. THE TIP OF THE SHORELINE INSERTER SNAPPED AT THE THREADS WHILE IMPLANTING THE WAVEFORM C INTERBODY. THE BROKEN TIP WAS UNABLE TO BE REMOVED FROM THE IMPLANT AND THE CONSTRUCT WAS LEFT IN-SITU WITHOUT A LOCKING COVER. THE EVENT DID NOT LEAD TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE REPORTER CONFIRMS THERE WAS NO PATIENT INJURY, AND THE ISSUE DID NOT REQUIRE ADDITIONAL MEDICAL OR SURGICAL TREATMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22031462 ↗MalfunctionApr 17, 2025Off-Label Use; Off-Label Use
IT WAS REPORTED ON (B)(6) 2024 THAT THREE (3) SHORELINE 3.5MM VARIABLE ANGLE (VA), SELF-TAPPING, 16MM SCREWS WERE INADVERTENTLY IMPLANTED INTO AN ADMIRAL CERVICAL PLATE DURING A MULTI-LEVEL ACDF PROCEDURE (C3-C7). THE SHORELINE SCREWS WERE USED IN COMBINATION WITH FIVE (5) ADMIRAL 4.0MM SCREWS IN A 3-LEVEL ADMIRAL PLATE CONSTRUCT. ACCORDING TO THE DISTRIBUTOR PRESENT IN THE OPERATING ROOM, THE SHORELINE SCREWS WERE PLACED PROXIMALLY, APPEARED FULLY SEATED, AND ALL LOCKING COVERS WERE VISIBLY ENGAGED. THE SURGEON ELECTED TO RETAIN THE CONSTRUCT AFTER CONFIRMING INTRAOPERATIVE STABILITY AND EXPRESSED CONFIDENCE IN THE FIXATION. NO ADVERSE PATIENT OUTCOME HAS BEEN REPORTED TO DATE. THIS EVENT INVOLVED THE OFF-LABEL USE OF SHORELINE SCREWS IN AN ADMIRAL PLATE SYSTEM, A COMBINATION THAT HAS NOT BEEN VALIDATED OR TESTED FOR CROSS-COMPATIBILITY. THE DISCREPANCY WAS IDENTIFIED POSTOPERATIVELY DURING A FOLLOW-UP DISCUSSION WITH THE DISTRIBUTOR AND TERRITORY MANAGER. NO PATIENT INJURY, EXPLANTATION, OR ADDITIONAL INTERVENTION WAS REQUIRED. AT THE TIME OF INITIAL COMPLAINT REVIEW, THE EVENT WAS DEEMED NON-REPORTABLE DUE TO THE ABSENCE OF HARM AND THE MECHANICAL INTEGRITY OF THE CONSTRUCT. HOW
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21859511 ↗
Other Seaspine Orthopedics Corporation products
- Mariner15 models · 147 reports · 1 recall
- Daytona Small Stature3 models · 14 reports · 2 recalls
- Fathom3 models · 2 reports · 2 recalls
- NorthStar24 models · 15 reports · 1 recall
- Meridian8 models · 8 reports · 1 recall
- Mariner Deformity3 models · 2 reports · 1 recall
- Virata25 models · 0 reports · 1 recall
- Reef TA2 models · 0 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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