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U.S. Department of Health and Human Services

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

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SEASPINE INC. NEWPORT NEWPORT DOUBLE LEAD SCREW, 8.5 X 45MM (4MM HEX) Back to Search Results
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.

 
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Brand NameNEWPORT
Type of DeviceNEWPORT DOUBLE LEAD SCREW, 8.5 X 45MM (4MM HEX)
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 Key10396448
MDR Text Key208131541
Report Number3012120772-2020-00058
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberK180176
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR
Reporter Occupation
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 Received08/12/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number64-8545
Device Catalogue Number64-8545
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/13/2020
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 TREATMENT DATA
Date Received: 08/12/2020 Patient Sequence Number: 1
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