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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - SCREWS SCREW, FIXATION, BONE

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OBERDORF SYNTHES PRODUKTIONS GMBH UNK - SCREWS SCREW, FIXATION, BONE Back to Search Results
Device Problem Unintended Movement
Event Type  Injury  
Manufacturer Narrative

Report is for an unknown spine screws/unknown lot. Part and lot numbers are unknown; udi number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. Reporter telephone number: (b)(6). 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: cavali, p. T. M. , landim, é. , pasqualini, w. And veiga, i. G. (1998), anterior cervical arthrodesis with morscher* plate: experience in 44 cases, revista brasileira de ortopedia, vol. 33 (2), pages 101-105 (brazil). The aim of this study is to report our experience and the results obtained using the morscher plate in several cervical pathologies. A total of 44 patients (27 male and 17 female) with a mean age of 46 years (range: 16-78) were included in the study. Surgery was performed using a cervical spine locking plate (cslp). The follow-up period was an average of 20 months (ranging from 6 to 48 months). The following complications were reported as follows: the patients with tetraplegia did not show any improvement in the neurological injury. A patient had loosening of a cranial screw and a caudal screw without loosening of the plate three months after surgery and presented with dysphagia. The patient underwent further surgery to remove the implants. A female patient had loosening of the two caudal screws and of this end of the plate four months after surgery, with dysphagia. She underwent further surgery to remove the implants. A patient had a plate fracture 10 months after surgery and presented with cervical pain. A patient had loosening of the two screws at the caudal end with loosening of this end of the plate three months after surgery. A patient had loosening of a screw at the caudal end of the plate. This is report 5 of 7 for (b)(4). This report is for unknown synthes spine screws.

 
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Brand NameUNK - SCREWS
Type of DeviceSCREW, 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 Key8949396
Report Number8030965-2019-67864
Device Sequence Number1
Product CodeHWC
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 08/02/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/30/2019
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/02/2019
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: 08/30/2019 Patient Sequence Number: 1
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