MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG UNKNOWN; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number MSB_UNK_SCREW

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/25/2023

Event Type  malfunction  

Event Description

Purpose: this study aims to compare the effect of using o-arm and c-arm fluoroscopy on the surgical outcomes of occipitocervical fixation.Methods: the study included patients who underwent occipitocervical fixation using o-arm or c-arm between 2005 and 2021.Of 56 patients, 34 underwent o-arm-assisted surgery (o-group) and 22 underwent c-arm-assisted surgery (c-group).We assessed surgical outcomes, including operative time, intraoperative blood loss, perioperative complications, and bone union.Results: almost half of the patients had rheumatoid arthritis-related disorders in both groups.Sixteen cases (47.1%) in the o-group and 12 cases (54.5%) in the c-group were fixed from occipito (oc) to c3, 12 cases (38.2%) in the o-group and 7 cases (31.8%) in the c-group from oc to c4-7, 5 cases (14.7%) in the o-group, and 3 cases (13.6%) in the c-group from oc to t2 (p ¼ 0.929).There was no significant difference in operative time (p ¼ 0.239) and intraoperative blood loss (p ¼ 0.595) between the two groups.Dysphagia was the most common complication in both groups (o-group vs.C-group, 11.7% vs.9.1%).Regarding implant-related complications, occipital plate dislodgement was observed in four cases (18.2%) in the cgroup (p ¼ 0.02).The bone union rate was 96.3% in the o-group and 93.3% in the c-group (p ¼ 1).Conclusions: o-arm use is associated with a reduced rate of occipital plate dislodgment and has a similar complication incidence compared with c-arm-assisted surgery and does not prolong operative time despite the time needed for setting and scanning.Accordingly, an o-arm is safe and useful for occipitocervical fixation surgery.Reportable event: general complications such as dysphagia happened for 6 patients, surgical site infection happened for 4 patients, pneumonia happened for 2 patients, duodenal ulcer happened in one patient and laryngeal edema happened for one patient.Three of the six cases of dysphagia had good alignment and spontaneously recovered.However, the remaining three cases did not recover due to poor alignment, where one case underwent reoperation and two cases did not follow-up.Complications related to implants were oc plate dislodgement in 4 patients, rod breakage in one patient and malalignment in 3 patients.

Manufacturer Narrative

Citation: keiji wadaa., shunichi moria., shuji shimamotob., tomohisa inoueb., ryo tamakib., ken okazakib.¿surgical outcomes of intr aoperative o-arm versus c-arm fluoroscopy in occipitocervical fixation: a retrospective analysis¿.British journal of neurosurgery.2023.Doi: 10.1080/02688697.2023.2297879 link to this article: https://doi.Org/10.1080/02688697.2023.2297879 a2: the average age of the patients was 67 years.This value is the average age of the patients reported in the article as specific patients could not be identified.A3a: the most common gender was female.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.B3: please note that this date is based off of the date of publication of article as the event dates were not provided in the published article.D4: product identifier is unknown.G4: 510(k) is unknown.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: UNKNOWN
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer (Section G): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 18958794
• MDR Text Key: 339338068
• Report Number: 1030489-2024-00200
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: No
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2024
• 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 Age: 67 YR
• Patient Sex: Female