MAUDE Adverse Event Report: SEASPINE INC. CORAL SPINAL SYSTEM; ROD

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Failure of Implant (1924); Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

A revision surgery occurred on (b)(6) 2018 to reattempt fusion by grafting l2-l3, l3-l4 and instrumenting t12-s2.The rod was not returned for analysis; however, the root cause of the reported failure is pseudarthrosis, or nonunion.Review of labeling: postoperative warnings surgeons should advise patients regarding the risks of surgery and the importance of post-operative compliance.The patient should be advised to limit and restrict physical activities, especially lifting and twisting motions and any type of sport participation.The patient should be advised that implants may bend, break or loosen despite restriction in activity.The patient should be advised to avoid mechanical vibrations that may loosen the device.The patient should be advised not to smoke or consume alcohol during recovery.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, vascular disorders, including thrombus; bronchopulmonary disorders, including emboli; bursitis, hemorrhage, myocardial infarction, paralysis or death.

Event Description

On 1 jun 2020, seaspine was made aware of a postoperative left rod fracture due to pseudarthrosis.The index surgery took place on (b)(6) 2017 and consisted of polyaxial screws, axial rod to rod connectors, locking caps, and rods from the coral spinal system, levels t10-s1.A revision surgery occurred on (b)(6) 2018 to re-instrument and realign the construct.

• Brand Name: CORAL SPINAL SYSTEM
• Type of Device: ROD
• Manufacturer (Section D): SEASPINE INC.; 5770 armada drive; carlsbad, ca
• Manufacturer (Section G): SEASPINE INC.; 5770 armada drive; carlsbad, ca
• Manufacturer Contact: audrey mudderman ; 5770 armada drive; carlsbad, ca ; 2165137
• MDR Report Key: 10219666
• MDR Text Key: 197571477
• Report Number: 3012120772-2020-00046
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2020
• 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): Required Intervention