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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 plate/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. (b)(4). 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: sengupta, d. K. , khazim, r. , grevitt, m. P. And webb, j. K. (2001), flexion osteotomy of the cervical spine: a new technique for correction of iatrogenic extension deformity in ankylosing spondylitis, spine, vol. 26 (9), pages 1068-1072 ((b)(6)). This study presents a case report of a (b)(6) year-old female patient who had global kyphotic deformity caused by ankylosing spondylitis underwent a flexion osteotomy of the cervical spine. Surgery was performed using cervical spine locking plate (stratec ltd. , welwyn garden city, uk). Paraesthesia developed in the patient¿s right c8 and t1 dermatomes during the immediate postoperative period. This problem was settled completely with halo-traction for two weeks. Immobilization was maintained with a halo-vest for 8 weeks, followed by a molded collar for another 6 weeks. At the 2-year follow-up assessment, the patient had no further complication, and her gaze angle was fully corrected. This report is for an unknown synthes plate. This is report 1 of 2 for (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 Key9010141
MDR Text Key162332558
Report Number8030965-2019-68223
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation
Type of Report Initial
Report Date 08/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/12/2019
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 Received08/15/2019
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: 09/12/2019 Patient Sequence Number: 1
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