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

Device Problem Fluid/Blood Leak (1250)

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

Event Date 01/26/2012

Event Type  malfunction  

Event Description

This report is being filed after the review of the following journal article: sun, r., maier, b., theilmann, l., and samie, a.A.(2012), thrombosis of the inferior vena cava in a patient with non-hodgkin¿s lymphoma and status post spine surgery, the internist, vol.53, pages 474¿477 (germany).This study presents a case report of an (b)(6) female patient had acutely decompensated spinal stenosis in the region of the lumbar vertebral bodies of l 2-3 and l 3-4 associated with neurological deficits, a thoracic spondylodesis with cement augmentation over the screws as well as l 2-4 laminectomy had been performed.Subsequently the patient had been largely asymptomatic.The postoperative ct of the lumbar spine had revealed mild leakage of the bone cement (vertecem®, synthes) into the venous vessels at the level of l2 and l4.At that time, enlarged abdominal lymph nodes seen on admission ct as well as anemia led to further evaluation and thus to the diagnosis of a highly malignant lymphoma, which was treated with 6 cycles of r-chop.Since the patient had remained symptom-free the entire time, anticoagulation was initiated for the following 6 months.The patient remained asymptomatic and sonographic follow-up control after 3 months showed extensive organization of the apposition thrombus.This report is for an unknown synthes vertecem.

Manufacturer Narrative

This report is for an unknown biomaterial - cement: vertecem/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.

• Brand Name: UNK - BIOMATERIAL - CEMENT: VERTECEM
• Type of Device: POLYMETHYLMETHACRYLATE BONE CEMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11846176
• MDR Text Key: 280689279
• Report Number: 8030965-2021-04026
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial
• Report Date: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/21/2021
• Initial Date FDA Received: 05/18/2021
• Patient Sequence Number: 1
• Patient Age: 81 YR