MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION SHORELINE ACS; 6-7MM, NO PROFILE LOCKING COVER

Model Number	85-2006
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device was not returned for evaluation.The lot number was not provided; therefore, a device history record review could not be performed.Attempts were made to obtain additional information; however, no further details were provided.The postoperative imaging provided indicates that the locking cover loosened/backed out as reported.The surgeon reported that intraoperative fluoroscopic imaging confirmed the locking cover was flush and properly seated at the conclusion of the index procedure on (b)(6) 2025.Due to the absence of the returned device and lack of additional information, the specific root cause cannot be conclusively determined.No patient injury, revision surgery, or additional medical intervention has been reported.The reported event is consistent with known potential adverse events described in the device labeling.Review of labeling: possible adverse events like other spinal system implants, the following adverse events are possible.This list is not exhaustive: bending, disassembly, or fracture of implant and components loosening of spinal fixation implants may occur due to inadequate initial fixation, latent infection, and/or premature loading, possibly resulting in bone erosion, migration, or pain.
Event or Problem Description
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.

• Brand Name: SHORELINE ACS
• Common Device Name: 6-7MM, NO PROFILE LOCKING COVER
• Manufacturer (Section D): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada dr.; carlsbad CA 92008
• Manufacturer (Section G): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada dr.; carlsbad CA 92008
• Manufacturer Contact: audrey mudderman ; 5770 armada dr.; carlsbad, CA 92008
• MDR Report Key: 24488463
• Report Number: 3012120772-2026-00003
• Device Sequence Number: 5017346
• Product Code: OVE
• UDI-Device Identifier: 10889981125042
• UDI-Public: 10889981125042
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 85-2006
• Device Catalogue Number: 85-2006
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 85-3316 3.5MM FIXED ANGLE SCREW, SELF DRILLING; AC4-185077 NO PROFILE SPACER, 18X15X7MM, 7 DEGREE
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown