MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - BIOMATERIAL - CEMENT: VERTECEM; POLYMETHYLMETHACRYLATE BONE CEMENT

Device Problems Leak/Splash (1354); Migration (4003)

Patient Problems Pulmonary Embolism (1498); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for unknown vertecem bone cement/unknown lot.Part and lot number 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.(b)(4).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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: ishak, b.Et al (2019), early complications and cement leakage in elderly patients who have undergone intraoperative computed tomography (ct)-guided cement augmented pedicle screw placement: eight-year single-center experience, world neurosurgery, vol.128 (xx), pages e975-e981 (germany).The aim of this retrospective study is to assess the complications associated with cement application in an elderly cohort and to assess whether ct-navigation is beneficial in preventing complications such as pce.Between may 2008 to december 2016, a total of 86 patients with a mean age of 73.4±5.1 years (range 65-86 years) were included in the study.All patients underwent cement augmented pedicle screw placement using ct-based point-to-point navigation.Surgery was performed using 4-5 navigation reference marker screws (matrixneuro 4-mm self-drilling screws; depuy synthes, raynham, massachusetts, usa).Posterior instrumentation was performed using a depuy spine or competitor's device.Then approximately 2-4 ml of polymethylmethacrylate was applied per vertebral body under intermittent x-ray fluoroscopy using vertecem bone cement (depuy synthes) or a competitor's device.The mean follow-up period was unknown.The following complications were reported: 1 patient (1%) died as the result of hemodynamic insufficiency after developing anaphylactic shock with intraoperative reanimation after cement was applied.55 patients had cement leakage, of whom 52 were asymptomatic and just 3 symptomatic.In all cases in which cement leakage occurred, the patients had at least perivertebral leakage with or without addition other locations.14 patients were found to have cement leakage in the inferior vena cava.3 patients were found to have cement leakage in the azygos vein.4 patients were found to have cement leakage in the epidural without any symptoms.4 patients had pulmonary cement embolism.Two patients developed a symptomatic pce.One of them developed dyspnea on the second postoperative day.A thoracic ct scan revealed embolism in the inferior vena cava, azygos vein, and right pulmonary artery.The other case developed dyspnea, which was evident in low oxygen saturation shortly after the operation; the thoracic ct scan detected cement embolism in the right pulmonary artery.Neither case needed intensive care treatment.Two patients were asymptomatic, but a routine ct scan undertaken because of intraoperative concerns detected cement embolism in 2 lobar arteries.Statistical analysis confirmed an increased risk for pce with an increasing number of augmented screws (p < 0.05).The number of cement augmented screws in patients with pce (mean 8 ± 4.3) was significantly greater than in patients without pce (5.3 ± 3.1).All patients with diagnosed pce were treated with 2 weeks of low-molecular-weight heparin followed by oral anticoagulation for at least 3 months.This was monitored by their physicians.This report is for an unknown synthes vertecem.This is report 2 of 2 for (b)(4).

• Brand Name: UNK - BIOMATERIAL - CEMENT: VERTECEM
• Type of Device: POLYMETHYLMETHACRYLATE BONE CEMENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10395522
• MDR Text Key: 202555441
• Report Number: 8030965-2020-05881
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/06/2020

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/06/2020
• Initial Date FDA Received: 08/12/2020
• 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
• Patient Outcome(s): Required Intervention