MAUDE Adverse Event Report: SEASPINE INC. COMPLETE CERVICAL STAND ALONE IBD; DRIVER - STRAIGHT

Model Number	27-40-0130
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	01/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The screwdriver was not returned for investigation and therefore could not be evaluated by product monitoring or engineering.During the review of the device history record for lot w19985, it was concluded that the product was inspected and accepted for use by the quality control team on november 18, 2014 and met all specified parameters of the receiving inspection report with no associated nonconformance specific to the product issue.Review of labeling: indications for use the complete cervical intervertebral body fusion device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the c2-c3 disc to the c7-t1 disc.Cervical disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.The complete cervical implants are to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and implanted via an anterior approach.The cervical device is to be used in patients who have had six (6) weeks of non-operative treatment.The cervical device is to be used with two titanium alloy screws which accompany the implant.Contraindications: any medical or surgical condition which would preclude the potential benefit of spinal implant surgery is a contraindication.The following conditions may reduce the chance of a successful outcome and should be taken into consideration by the surgeon.This list is not exhaustive: absolute contraindications: infection in or around the operative site, allergy or sensitivity to implant materials, any case not described in the indication, relative contraindications: local inflammation, morbid obesity, pregnancy, fever or leukocytosis, prior fusion at the level(s) to be treated, grossly distorted anatomy due to congenital abnormalities, rapid joint disease, bone absorption, osteopenia, and/or osteoporosis, elevation of sedimentation rate unexplained by other diseases, elevation of white blood count (wbc), or a marked left shift in the wbc differential count any case not requiring bone graft and fusion or where fracture healing is not required patients having inadequate tissue coverage over the operative site or where there is inadequate bone stock, bone quality, or anatomical definition unsuitable or insufficient bone support bone immaturity the patient's activity level, mental condition, occupation and/or a patient unwilling to cooperate with the postoperative instructions any case where implant utilization would interfere with anatomical structures or expected physiological performance use of incompatible components and/or materials from other systems 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 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 spine secondary to severe spondylolisthesis, 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 condition is unknown.The implantation of this system should be performed only by experienced spinal surgeons with specific training in the use of this device because this is a technically demanding procedure presenting a risk of serious injury to the patient.Based on the fatigue testing results, the surgeon should consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc.Which may impact the performance of the system ensure all implants, components or instruments are sterilized prior surgery.The use of non-sterile devices may lead to inflammation, infection or disease.Implants should never be reused under any circumstances.A used implant should be discarded.While the implant may appear undamaged, it may have small defects or internal stress patterns and if implanted, could fail to perform as intended and pose safety risks to the patient.The risks include, but are not limited to, mechanical failure, breakage, difficulty with implantation, incompatibility with mating components and infection.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.
Event or Problem Description
On (b)(6) 2020, the patient underwent anterior cervical fixation using the complete cervical stand alone ibd.Seaspine was informed the screwdriver broke while implanting a screw.The broken piece was left in the screw, inside the patient.No injury was reported, nor any additional medical or surgical treatment.

• Brand Name: COMPLETE CERVICAL STAND ALONE IBD
• Common Device Name: DRIVER - STRAIGHT
• Manufacturer (Section D): SEASPINE INC.; 5770 armada drive; carlsbad, ca
• MDR Report Key: 9750929
• Report Number: 3012120772-2020-00012
• Device Sequence Number: 14056264
• Product Code: ODP
• UDI-Device Identifier: 10889981115746
• UDI-Public: 10889981115746
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K172926
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 27-40-0130
• Device Catalogue Number: 27-40-0130
• Device Lot Number: W19985
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2020
• Initial Report FDA Received Date: 02/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1