MAUDE Adverse Event Report: SEASPINE INC. NEWPORT; NEWPORT DOUBLE LEAD SCREW, 8.5 X 45MM (4MM HEX)

Model Number 64-8545

Device Problem Mechanical Problem (1384)

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

Event Date 07/11/2020

Event Type  Injury  

Manufacturer Narrative

The newport screw and mating cap/rod have not been returned for investigation; however, based on the photos provided, the screw head or tulip fractured.Once fractured, the screw shaft may loosen and/or detach from the screw head and overall construct.It is unknown if the fracture occurred upon insertion or if the fracture is due to the patient's anatomy or related comorbidities.The location of the screw (s1) and fracture suggests either the surgeon used this screw as a point of leverage while continuing up the construct and therefore damaged the screw intra-operatively due to excessive loads placed on the device or the fracture occurred post-operatively as a result of the construct load bearing on the lowest level.Cross threading or over torquing of the set screw are additional factors that and may have contributed to the failure pictured.This investigation is ongoing, pending the return of the implants.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, vascular disorders, including thrombus; bronchopulmonary disorders, including emboli; bursitis, hemorrhage, myocardial infarction, paralysis or death.Warnings and precautions patients with previous spinal surgery at the level(s) to be treated may have different clinical outcomes compared to those without previous surgery.The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation.These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the l5-s1 vertebra, degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).The safety and effectiveness of these devices for any other conditions are unknown.

Event Description

The patient underwent revision surgery on (b)(6) 2020 due to suspected infection and bone loss.The construct consisted of seaspine's newport spinal system l4-s1.On (b)(6) 2020, seaspine was made aware that the right s1 newport double lead screw, 8.5 x 45mm (4mm hex) (64-8545) had disassembled in-situ 10 days after it was implanted.On (b)(6) 2020, the surgeon revised the patient, replaced the affected screw, and increased the support of the construct given the patient's pre-existing issues.The patient was reported to be doing well; there were no complications during the revision surgery and the fixation and stability achieved was optimal from a clinical standpoint.

Manufacturer Narrative

The failure mode has been identified as application of excess force during intra-operative construct tightening based on the physical condition of the implant.Inspection indicates application of excessive torsional stress, most probably occurring during intra-operative final-tightening of the construct, as evidenced by the damage to the 64-8545 screw tulip and the mating rod/cap combo (60-0375).As noted above, fall/impact cannot be ruled out as a potential contributor to post-operative fracture.The failure mode has not previously been observed.

• Brand Name: NEWPORT
• Type of Device: NEWPORT DOUBLE LEAD SCREW, 8.5 X 45MM (4MM HEX)
• Manufacturer (Section D): SEASPINE INC.; 5770 armada drive; carlsbad, ca
• MDR Report Key: 10396448
• MDR Text Key: 208131541
• Report Number: 3012120772-2020-00058
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10889981125585
• UDI-Public: 10889981125585
• Combination Product (y/n): N
• PMA/PMN Number: K180176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 64-8545
• Device Catalogue Number: 64-8545
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention