MAUDE Adverse Event Report: SeaSpine Orthopedics Corporation Shoreline ACS; DTS Guide Inserter

Model Number	86-1000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Event or Problem Description
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.
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.Additionally, no postoperative imaging was provided for evaluation and as a result the reported event cannot be confirmed.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.Review of labeling: intra-operative warnings: breakage, slippage, or misuse of instruments or implant components may cause injury to the patient or operative personnel.

• Brand Name: Shoreline ACS
• Common Device Name: DTS Guide Inserter
• 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: amanda fonseca ; 5770 armada dr.; carlsbad, CA 92008 ; +1(760)216-5655
• MDR Report Key: 50145684
• Report Number: 3012120772-2026-00039
• Device Sequence Number: 18419513
• Product Code: OVE
• UDI-Device Identifier: 10889981127411
• UDI-Public: 10889981127411
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 86-1000
• Device Catalogue Number: 86-1000
• Device Lot Number: EM2306031D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2026
• Supplement Date Received by Manufacturer: 08/17/2026
• Initial Report FDA Received Date: 08/05/2026
• Supplement Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/02/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown