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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - SCREWS THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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OBERDORF SYNTHES PRODUKTIONS GMBH UNK - SCREWS THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dysphagia/ Odynophagia (1815); Dyspnea (1816)
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown cervical 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. 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: kyung-jin song et. Al (2012), efficacy of postoperative radiograph for evaluating the prevertebral soft tissue swelling after anterior cervical discectomy and fusion, clinics in orthopedic surgery vol. 4(1), pages 77-82 (korea south). Doi: 10. 4055/cios. 2012. 4. 1. 77. The aim of this study was to evaluate the clinical significance of prevertebral soft tissue swelling (psts) after anterior cervical fusion with plate fixation for the treatment of degenerative cervical spinal disorders. Between april 2004 and june 2007, a total of 135 patients (78 males and 57 females) with a mean age of 54. 8 years (ranges, 30-86 years) were included in the study. These patients were separated into 2 groups. Group a has 71 patients (37 males and 34 females) with a mean age of 51. 56 and group b has 64 patients (41 males and 23 females) with a mean age of 53. 64. These patients underwent anterior cervical fusion with plate augmentation for degenerative cervical spondylosis. Cases were divided into one level fusion group and two or more-level fusion group for comparison purposes. For the anterior stabilization, the cervical spine locking plate was used. The mean duration of follow-up was 38. 7 months. The following complications reported as follows: group a: there were 4. 15 ± 5. 6 that had psts (prevertebral soft tissue swelling) 3 patients had dysphagia. 4 patients had dyspnea. Group b: there were 11. 32 ± 3. 9 that had psts (prevertebral soft tissue swelling) 13 patients had dysphagia. 6 patients had dysphonia. 12 patients had dyspnea. This is report 2 of 2 for (b)(4). This report is for an unknown synthes an unknown synthes cervical screws.
 
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Brand NameUNK - SCREWS
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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 Key9152510
MDR Text Key166784216
Report Number8030965-2019-68979
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeKS
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 09/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/03/2019
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 Received09/11/2019
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: 10/03/2019 Patient Sequence Number: 1
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