MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN BIOMATERIAL - CEMENT; POLYMETHYLMETHACRYLATE BONE CEMENT

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

Patient Problem Pulmonary Embolism (1498)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: 510k: this report is for an unknown biomaterial - cement/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This report is being filed after the review of the following journal article: moser m., jost j., and nevzati e.(2021), kyphoplasty versus percutaneous posterior instrumentation for osteoporotic vertebral fractures with posterior wall injury: a propensity score matched cohort study, journal of spine surgery, vol.7 (1), pages 68-82 (switzerland).The aim of this retrospective, propensity score-matched cohort study is to evaluate our centers procedural data, surgical results, and perioperative complications in a cohort of patients with ovfs with posterior wall injury who underwent treatment with bkp with or without percutaneous posterior instrumentation.Between january 2010 to december 2018, a total of 50 patients (7 male and 43 female) with a mean age of 74.4¿9.5 years, who underwent balloon kyphoplasty with or without percutaneous posterior instrumentation with pedicle screws, were included in the study.These patients were divided into 2 groups based on surgical treatment received.Percutaneous instrumentation was performed using viper¿ 2 (depuy synthes spine, oberdorf, switzerland) until 2015, and a competitor from 2016 to 2018.Bkp was performed using confidence spinal cement system¿ (depuy synthes spine, oberdorf, switzerland) and a competitor device.The average follow-up was 8.4 months (range, 156.4 months).The following complications were reported as follows: bkp group: 6 patients developed a complication within 30 days after surgery, 4 of which required drug treatment due to urinary tract infection (n=1), hypokalemia (n=1), hypertensive crisis (n=1), and hypertensive crisis, hyperkalemia, and hyponatremia (n=1).1 patient had moderate complication (complicated urinary tract infection requiring suprapubic catheter) and 1 had a severe complication (acute pericarditis).13 patients had opioid use at discharge.2 patients were readmitted within 30-day.3 patients had opioid use at 3-month follow-up.11 patients had subsequent fractures within 3-month follow-up.4 patients showed fracture progression of the cement augmented level, which was managed conservatively in all cases.An unknown number of patients had an average loss of correction of 3.8¿ in the sagittal cobb angle, 2.8¿ in the vertebral wedge angle, and 2.2 mm in the anterior vertebral height.7 patients had cement leakage.Of these, 2 occurred intraspinally which was asymptomatic, and 5 ventrally or laterally confined to vertebral level.Ps group: 11 patients developed a complication within 30 days after surgery, 10 of which required drug treatment due to urinary tract infection (n=2), anemia requiring transfusion of red bloods cells (n=1), delirium (n=1), fluid overload and hyponatremia (n=1), pulmonary cement embolism (dyspnea) requiring anticoagulation, hyponatremia, hypokalemia, anemia requiring transfusion of red blood cells, urinary tract infection (n=1), pulmonary embolism (n=1), pulmonary embolism, delirium, pneumonia (n=1), urinary tract infection, hypokalemia (n=1), transient proximal muscle weakness in the right leg and subsequent fracture of lower instrumented vertebra (l4) (n=1).1 patient had moderate complication (obstructive micturation requiring suprapubic catheter).21 patients had opioid use at discharge.1 patient was readmitted within 30-day.4 patients had opioid use at 3-month follow-up.9 patients had subsequent fractures within 3-month follow-up.2 of these patients who received instrumentation two levels above and one level below the index level: one was managed conservatively, and another underwent revision surgery with caudal extension of the instrumentation 83 days after the index procedure.An unknown number of patients had an average loss of correction of 1.6¿ in the vertebral wedge angle, and 2.3 mm in the anterior vertebral height.11 patients had cement leakage.Of these, 9 occurred ventrally or laterally confined to vertebral level, 1 ventrally or laterally >1 level, and 1 occurred at the adjacent level.This report is for an unknown depuy spine viper 2 constructs and unknown depuy spine confidence cement.

• Brand Name: UNKNOWN BIOMATERIAL - CEMENT
• Type of Device: POLYMETHYLMETHACRYLATE BONE CEMENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 6103142063
• MDR Report Key: 12468465
• MDR Text Key: 271494898
• Report Number: 1526439-2021-01994
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1