MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG UNKNOWN

Model Number MSB_UNK_SCREW

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Extravasation (1842); Pain (1994)

Event Date 12/03/2018

Event Type  Injury  

Manufacturer Narrative

Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.As per the medical safety assessment, the reported events as labeled complications per ifu (m708348b093e rev.F) and/or are predicted in this patient population.Product identifier is unknown, hence 510k# is not available.If information is provided in the future, a supplemental report will be issued.

Event Description

Ori barzilai, md, lily mclaughlin, bs, eric lis, md, anne s.Reiner, mph, mark h.Bilsky, md, ilya laufer, md.Utility of cement augmentation via percutaneous fenestrated pedicle screws for stabilization of cancer-related spinal instability.Operative neurosurgery 16:593¿599, 2019.Doi: 10.1093/ons/opy186.Summary: cancer patients experience pathological fractures and the typical poor bone quality frequently complicates stabilization.Methods for overcoming screw failure include utilization of fenestrated screws that permit the injection of bone cement into the vertebral body to augment fixation.Bone quality is typically poor in cancer patients due to the osteolytic metastases, chemotherapy, radiation, and other comorbidities.This is a retrospective chart and imaging review at a tertiary cancer center between april 2016 and august 2017.Patients with neoplastic spinal instability who underwent percutaneous instrumented spinal stabilization with cement augmentation using fenestrated pedicle screws (medtronic, dublin, ireland) and were followed up clinically, radiologically or both at least 6 wk postoperatively at time of data collection were included.After verification of proper screw positioning, pmma was injected bilaterally at each level through the fenestrated screws under flu oroscopic guidance.In cases where cement extravasation is suspected, as suggested by fluoroscopy, injection of cement is stopped.Fifty-three patients were included in the analysis (30 male, 57%).Median age at the time of surgery was 63.5 yr.The most common pa thologies were lung and renal cell carcinoma with a similar distribution among spine segments across the study cohort with 38% thoracic, 36% lumbar, and 26% in the thoracolumbar region.The data presented demonstrate that when properly placed, the risks of hardware failure including screw pull out, instrumentation breakage, or lucency are low.The use of fenestrated screws facilitates this process with low morbidity and short operative times.Event: one patient had an asymptomatic screw fracture at 6 mo postoperatively that did not require intervention.Intraoperative suspicion of cement extravasation either anteriorly to a draining blood vessel or posteriorly towards the spinal canal was suspected in 17 cases prompting cessation of cement injection, of which 1 patient had evidence of cement embolus in the pulmonary artery.This radiological finding did not require intervention as at the time the patient remained asymptomatic.Three patients required a reoperation.One patient presented at 3-mo follow-up with recurrence of mechanical back pain.Radiographic evidence demonstrated pull out of the bottom screws of her construct.Interestingly, intraoperative images demonstrated a paucity of cement injected into these screws as there was suspicion of cement extravasation prompting cessation of cement injection during the initial surgery.She was subsequently taken for hardware revision.Another patient required revision of instrumentation secondary to a fracture of an instrumented pedicle 1 mo after the initial surgery.One patient required a wound revision due to dehiscence while receiving bevacizumab systemic complications included a pulmonary cement embolism, a lower extremity deep vein thrombosis, and a postoperative mortality secondary to pulmonary failure from widespread metastatic pulmonary infiltration.

• Brand Name: UNKNOWN
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• MDR Report Key: 12390155
• MDR Text Key: 280703443
• Report Number: 1030489-2021-01102
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Type of Report: Initial
• Report Date: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MSB_UNK_SCREW
• Device Catalogue Number: MSB_UNK_SCREW
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/06/2021
• Initial Date FDA Received: 08/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention