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U.S. Department of Health and Human Services

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

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OBERDORF SYNTHES PRODUKTIONS GMBH UNK - BIOMATERIAL - CEMENT: VERTECEM POLYMETHYLMETHACRYLATE BONE CEMENT Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bone Fracture(s) (1870); Neurological Deficit/Dysfunction (1982); Pain (1994); Impaired Healing (2378); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
There are multiple patients all information is provided in the article. This report is for an unknown biomaterial - cement: vertecem/unknown lot. Part and lot number are unknown; udi number is unknown. Implant date is between (b)(6) 2009 and (b)(6) 2014. 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. (b)(4).
 
Event Description
This report is being filed after the review of the following journal article: spiegl u, et al. (2019), hybrid stabilization of unstable osteoporotic thoracolumbar vertebral body fractures: clinical and radiological outcome after a mean of 4 years, european spine journal, volume 28, page 1130-1137, (germany). The aim of this study was to evaluate the clinical and radiographic midterm results of hybrid stabilization for the treatment of unstable burst fractures of the thoracolumbar spine in patients aged 60 years or higher under consideration of the spinopelvic alignment. Between december 2009 and may 2014, 113 patients with unstable osteoporotic vertebral body fracture at the thoracolumbar spine and were stabilized using hybrid stabilization consisting of short-segmental posterior instrumentation and augmentation of the fractured vertebral body were included in the study. There were 72 women and 41 men with a mean age of 74. 6+/-6. 8 years. Hybrid stabilization was done minimally invasive by posterior cement-augmented short-segmental stabilization without fusions using an unknown synthes matrix and other competitor devices, and bilateral transpedicular kyphoplasty of the fractured vertebral body using an unknown synthes vertecem. All pedicle screws were cement augmented. Clinical and conventional radiological assessment was performed at 2 weeks, 6 weeks, 3 months, and 12 months postoperatively. All patients were followed up for a minimum of 24 months after initial surgery. A total of 69 patients were followed over an average of 48 months (range: 24-78 months). The authors did not specify which patients were implanted with the depuy synthes device. Thus, complications will be reported as follows: 17 patients who have been lost to follow-up have died during the follow-up period. A (b)(6) year-old female patient had mild temporary pain, mild limitations, and mild reduction loss as well as compensated sagittal balance at the latest follow-up 26 months postoperatively. 29 patients had persistent pain and gained relevant loss of reduction after mobilization. 4 patients had high loss of reduction (more than 19 degrees). Unknown patients had minor loss of reduction (less than 5 degrees). Unknown patients had moderate loss or reduction (more than 5 degrees but less than 10 degrees. ) 1 patient had an incomplete conus cauda syndrome after surgery. An mri on the same day of surgery diagnosed severe spinal canal stenosis at the fracture level without cement leakage or screw displacement. Emergency revision surgery with decompression of the affected segment was performed. The neurologic deficit recurred completely afterward. 3 patients had impaired wound healing postoperatively. The all had revision surgery after an average of 6 days (range: 4-8). 1 patient had pneumonia and received antibiotics intravenously. 12 patients suffered from further adjacent or different level vertebral body fractures and 2 patients from further osteoporotic fractures (proximal humerus, femoral neck fracture). 5 of these patients had more than one further vertebral body fracture (mean: 4. 2; range 2-6). Revision surgery was done in 12 patients with additional osteoporotic fractures. A (b)(6) year-old patient had further osteoporotic fractures at th11 and l3-5 and was revised. This patient had severe limitation per oswestry disability index (odi) score. An (b)(6) year-old patient had further osteoporotic fractures at th10 and l1 and was revised. This patient had severe limitation per oswestry disability index (odi) score. A (b)(6) year-old patient had further osteoporotic fractures at th 5-7 and femoral neck fracture and was revised. This patient had severe limitation per oswestry disability index (odi) score. An (b)(6) year-old patient had severe limitation per oswestry disability index (odi) score. A (b)(6) year-old patient had further osteoporotic fracture at the proximal humerus and was revised. This patient had severe limitation per oswestry disability index (odi) score. This report is for an unknown synthes matrix and an unknown synthes vertecem. This report is for one (1) unknown biomaterial - cement: vertecem. This is report 1 of 8 for (b)(4). This complaint is linked to (b)(4).
 
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Brand NameUNK - BIOMATERIAL - CEMENT: VERTECEM
Type of DevicePOLYMETHYLMETHACRYLATE BONE CEMENT
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key10005566
MDR Text Key194512118
Report Number8030965-2020-03152
Device Sequence Number1
Product Code NDN
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/09/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/28/2020 Patient Sequence Number: 1
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