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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - BIOMATERIAL - PREFORMED: CHRONOS STRIP: SPINE POLYMETHYLMETHACRYLATE BONE CEMENT

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SYNTHES GMBH UNK - BIOMATERIAL - PREFORMED: CHRONOS STRIP: SPINE POLYMETHYLMETHACRYLATE BONE CEMENT Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Nerve Damage (1979); Pain (1994)
Event Type  Injury  
Manufacturer Narrative
510k: this report is for an unknown chronos strip/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. 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: hrabálek l. , wanek t. , and adamus m. (2010), xlif ¿ a new technique of the lumbar vertebra replacement: initial experience, rozhledy v chirurgii, vol. 89 (12), pages 784-788 (czech republic). The aim of this study is a description of the surgical procedure of xlif, its difficulties and advantages, based on our experiences with first patients. Between november 2009 to february 2010, a total of 11 patients with age ranging from 28 to 67 years were included in the study. Surgery was performed using oracle implants (synthes, usa) and strips from beta-tricalcium phosphate (chronos strip, synthes, usa). The mean follow-up period was unknown. The following complications were reported: in the first operated patient, an l5 nerve root traction occurred on the left during l4/5 surgery as a result of excessive expansion of the space where the implant was inserted by the expansion device. This resulted in a temporary and partial paresis and dermatomal hyperesthesia of l5 on the left, the patient reported no pain. 2 patients complained of transient painful flexion in the left hip as a result of a trans-psoatic approach, one patient immediately after surgery and the other after 1 week. This report is for an unknown synthes oracle cage and unknown synthes chronos strip. This is report 1 of 2 for (b)(4).
 
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Brand NameUNK - BIOMATERIAL - PREFORMED: CHRONOS STRIP: SPINE
Type of DevicePOLYMETHYLMETHACRYLATE BONE CEMENT
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12341818
MDR Text Key267247964
Report Number8030965-2021-06826
Device Sequence Number1
Product Code NDN
Combination Product (y/n)N
Reporter Country CodeEZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation
Type of Report Initial
Report Date 07/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/19/2021
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 Received07/21/2021
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: 08/19/2021 Patient Sequence Number: 1
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