MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION SHORELINE ACS; Intervertebral fusion device with integrated fixation, cervical

Device Problem Insufficient Information (3190)

Patient Problem Paralysis (1997)

Event Type  Injury  

Event Description

On 15 aug 2022, seaspine was made aware of the following clinical study abstract: hani malone, md et al., "early outcomes of multilevel acdf with segmental plate fixation." the objective of the study was to assess the clinical and radiographic outcome of segmental plate fixation in multilevel acdf at 1 year.66 patients with one-year follow up were included in the analysis.It was identified that four (6.1%) patients experienced a complication; 3 (4.5%) c5 palsy, 1(1.5%) hematoma.Importantly, no patients required reoperation for pseudoarthrosis or instrumentation failure.No further details were provided.Product part and lot numbers were not identified.This report is for 4 of 4 patients (c5 palsy).

Manufacturer Narrative

No part or lot numbers were provided.Review of labeling: possible adverse events like other spinal system implants, the following adverse events are possible.This list is not exhaustive: delayed union or nonunion (pseudarthrosis) 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, discomfort, or abnormal sensations due to the presence of the device pressure on skin where inadequate tissue coverage exists over the implant, with potential extrusion through the skin dural leak requiring surgical repair cessation of growth of the fused portion of the spine subsidence of the implant into adjacent bone loss of proper spinal curvature, correction, height and/or reduction increased biomechanical stress on adjacent levels improper surgical placement of the implant causing stress shielding of the graft or fusion mass intraoperative fissure, fracture, or perforation of the spine postoperative fracture due to trauma, defects, or poor bone stock serious complications associated with any surgery may occur.These include, but are not limited to: wound complications, infection, genitourinary disorders, gastrointestinal disorders, respiratory disorders; cardiovascular disorders, including myocardial infarction (heart attack) or arrythmias; neurologic injuries resulting in weakness, paralysis, numbness, tingling, or pain; vascular (blood vessel) injuries, hemorrhage (bleeding); thrombosis (blood clots) leading to deep venous thrombosis or pulmonary embolism, or death.

• Brand Name: SHORELINE ACS
• Type of Device: Intervertebral fusion device with integrated fixation, cervical
• 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: taara maharaj ; 5770 armada dr.; carlsbad, CA 92008
• MDR Report Key: 15419093
• MDR Text Key: 299871791
• Report Number: 3012120772-2022-00041
• Device Sequence Number: 1
• Product Code: OVE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K210497
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Literature
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other