Shoreline ACS 86-0010Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10889981126889), received between Aug 5, 2024 and Mar 6, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Fracture” (7 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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionMar 26, 2025Fracture; Fracture

  THE SURGEON REPORTED THE TIP OF THE SHORELINE ACS INSERTER BROKE WHILE PERFORMING SURGERY ON (B)(6) 2025. THE TIP OF THE INNER SHAFT OF THE INSERTER SHEARED OFF IN THE FACE OF THE IMPLANT. THE SURGEON DETERMINED THE TRAUMA THAT WOULD BE CAUSED BY REMOVING THE IMPLANT WOULD BE TOO GREAT TO DO SO, THEREFORE THE IMPLANT WAS LEFT IN-SITU. THE EVENT DID NOT LEAD TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE AND THE SURGERY WAS COMPLETED SUCCESSFULLY. CUSTOMER 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 21702052 ↗
• MalfunctionMar 11, 2025Fracture; Fracture

  THE SURGEON REPORTED THE TIP OF THE SHORELINE ACS INSERTER BROKE WHILE PERFORMING SURGERY ON (B)(6) 2025. THE TIP OF THE INSERTER BROKE OFF AS THE SURGEON WAS GETTING THE CAGE IN PLACE. THE SURGEON LEFT THE CAGE WITH THE INSERTER TIP IN PLACE WITHOUT THE 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. CUSTOMER 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 21578029 ↗
• MalfunctionJan 20, 2025Fracture; Fracture

  THE SURGEON REPORTED THE TIP OF THE SHORELINE ACS INSERTER BROKE WHILE PERFORMING SURGERY ON (B)(6) 2024. THE CAGE/PLATE WAS BEING IMPACTED INTO THE C6-C7 DISC SPACE WHEN THE THREADED TIP BROKE IN THE CAGE. THE TIP BECAME STUCK IN THE CAGE AND THE CAGE WITH THE BROKEN TIP WAS IMPLANTED IN THE PATIENT. THE SURGEON WAS UNABLE TO PLACE THE LOCKING COVER ON THE PLATE. THE CUSTOMER STATES THERE WAS A BACKUP AVAILABLE, BUT THE SURGEON WAS PLEASED WITH THE SCREW PURCHASE AND DECIDED TO LEAVE AS IS. THE EVENT DID NOT LEAD TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE AND THE SURGERY WAS COMPLETED SUCCESSFULLY. CUSTOMER 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 21194464 ↗
• MalfunctionJan 10, 2025Fracture; Fracture

  THE SURGEON REPORTED THE TIP OF THE SHORELINE ACS INSERTER BROKE WHILE PERFORMING SURGERY ON (B)(6) 2024. THE DISTAL TIP OF THE INSERTER WAS LEFT IN THE PATIENT. CUSTOMER CONFIRMS THERE WAS NO PATIENT INJURY, NO DELAY IN SURGERY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE ISSUE DID NOT REQUIRE ADDITIONAL MEDICAL OR SURGICAL TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21127982 ↗
• MalfunctionAug 5, 2024Fracture; Fracture

  ON (B)(6) 2024 A PATIENT UNDERWENT SPINAL SURGERY CONSISTING OF SEASPINE'S SHORELINE ANTERIOR CERVICAL FIXATION SYSTEM. DURING THE PROCEDURE, THE TIP OF THE INSERTER BROKE OFF IN THE INTERBODY IMPLANT. THE SURGEON OPTED TO LEAVE THE IMPLANT WITH THE BROKEN INSERTER TIP IN-SITU. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19911748 ↗