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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - PLATES: SPINE PLATE, FIXATION, BONE

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OBERDORF SYNTHES PRODUKTIONS GMBH UNK - PLATES: SPINE PLATE, FIXATION, BONE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Nerve Damage (1979); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown angle-locking implant cslp morscher plate/unknown lot. Part and lot number are unknown. Without the specific part number; the udi number and 510-k number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. (b)(4). 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: hofmeister, m. , and burhen, v. (1999), therapeutic concept for injuries of the lower cervical vertebral column, der orthopade, vol. 28(5), pages 401-413 (germany). The aim of this study is to present the therapeutic concept for injuries of the lower cervical vertebral column. A total of 69 cases were treated with an unknown synthes angle-locking implant cslp morscher plate. The following complications were reported as follows: 9 cases had blood vessels of the neck. Ligatures of the superior and inferior thyroid artery were recorded. 6 cases had nerves of the neck. 5 cases had soft tissue of the neck. A thyroid lesion, an esophageal lesion and 3 laryngeal lesions were found. 6 cases had nerves of the neck. It affected the recurrent nerve in 5 cases and the hypoglossal nerve in 1 case. 6 cases had ventral revisions and 3 cases had dorsal revisions. 41 patients still had a complete paralysis pattern postoperatively. In the case of incomplete paralysis symptoms of asia classification level c and d, a clear improvement or even complete recovery was seen in around half of patients. 2 patients with normal neurological status preoperatively saw a worsening recorded in the postoperative check. A complete paralysis pattern was developed over time in one patient with a gunshot wound in the cervical spine area. This is for an unknown synthes angle-locking implant cslp morscher plate. This is report 1 of 2 for complaint (b)(4).
 
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Brand NameUNK - PLATES: SPINE
Type of DevicePLATE, FIXATION, BONE
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 Key9100936
MDR Text Key159515250
Report Number8030965-2019-68529
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 08/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/20/2019
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 Received08/27/2019
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: 09/20/2019 Patient Sequence Number: 1
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