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

Model Number MSB_UNK_UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Urinary Tract Infection (2120); Numbness (2415); Spinal Cord Injury (2432); Post Operative Wound Infection (2446); Unspecified Nervous System Problem (4426)

Event Date 04/15/2021

Event Type  Injury  

Event Description

Jwalant pate, vishal kundnani, suraj kuriya: ¿a decade with micro-tubular decompression¿: peri-operative complications and surgical outcomes in single and multilevel lumbar canal stenosis.Https://doi.Org/10.1007/s00264-021-05032-2.A retrospective review of prospectively collected data over a period of ten years involving 625 patients who underwent single/multilevel lumbar mtd.Peri-operative clinical-radiological parameters, post-operative complications, clinical outcome (vas and odi), and satisfactory outcomes in the form of wang and bohlmann¿s criteria were evaluated.The metrx system (16¿22 mm tubes, medtronics, memphis, tn, usa) was used for the operation.The authors have divided the perioperative complications into five broad groups based on time of occurrence (early: 3 months post surgery and late: 3 months post surgery), severity of complications, and with respect to the system affected.A total 302 patients were found to have single-level stenosis, 267 were with two-level stenosis and 56 were with three-level stenosis (table 1).The most common level of stenosis or mtd was l4¿l5 (50.8%) followed by l3¿l4 (38.0%) and l5¿s1 (11.0%) (table 2).The unilateral stenosis was found in 58.24% patients (ipsilateral decompression done only), while 41.76% patients were with bilateral stenosis (ipsi- and contralateral decompression).The single incision was taken in 55.52% cases (single or multilevel), while multiple separate incisions were taken in 44.48% cases of multilevel stenosis.The intraoperative dural tears were found in 6/124 (4.83%) patients during the initial three years, while 4/501 (0.79%) cases developed dural dear in last seven years.Out of these ten dural tear cases, four cases were with major dural tears and required conversion to open surgery, while others were minor tears and were managed with fibrin glue applied locally through tube and watertight fascia closure.The most common complications were urinary tract infections (uti), syndrome of inappropriate anti-diuretic hormone secretion (siadh), superficial surgical wound infections, and transient/permanent paresthesia.A total five patients required revision surgeries due to inadequate decompression (managed with open decompression after clinico-radiological evaluation) and postoperative iatrogenic instability (managed with micro-tubular transforaminal interbody fusion-tlif) in cases with single level mtd.

Manufacturer Narrative

This value is the average age of the patients reported in the article as specific patients could not be identified.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.Please note that this date is based off of the date of publication of the article as the event dates were not provided in the published literature.If information is provided in the future, a supplemental report will be issued.

• Brand Name: METRX
• 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: 13074009
• MDR Text Key: 286584251
• Report Number: 1030489-2021-01588
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/23/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: MSB_UNK_UNKNOWN
• Device Catalogue Number: MSB_UNK_UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/10/2021
• Initial Date FDA Received: 12/23/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male