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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - MONO/POLYAXIAL SCREWS: CLICK'X THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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OBERDORF SYNTHES PRODUKTIONS GMBH UNK - MONO/POLYAXIAL SCREWS: CLICK'X THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Paresis (1998); Non-union Bone Fracture (2369)
Event Type  Injury  
Manufacturer Narrative
This report is for unknown pedicle 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: ricarda lechner et. Al (2017), fusion rate and clinical outcome in anterior lumbar interbody fusion with beta-tricalcium phosphate and bone marrow aspirate as a bone graft substitute. A prospective clinical study in fifty patients, international of orthopaedics vol. 41(2), pages 333-339 (austria). The aim of this study is to assess the safety and efficacy of b-tricalcium phosphate (b-tcp) in instrumented anterior lumbar interbody fusion (alif) procedure. A total of 50 patient (31 males and 19 females) age ranges 18 and 80 years old were included in the study. These patients had lower-back pain and degenerative disc disease (ddd) or degenerative spondylolisthesis between l3 and s1 and were treated with syncage synthes and unknown synthes pedicle screw. The mean duration of follow-up was 12 months. The following complications were reported as follows: 1 patient had paresis l5. 1 patient had hematoma. 1 patient had vessel lesion. 14 levels showed inadequate fusion anteriorly, (5 pseudoarthrosis, 9 probably not fused). 8 patients had pseudoarthrosis at 3 months x-ray assessment. 1 patient had pseudoarthrosis at 12 months x-ray assessment. 34 patients had probably not fused at 3 months x-ray assessment. 19 patients had probably not fused at 6 months x-ray assessment. 8 patients had probably not fused at 12 months x-ray assessment. 1 patient had migration of cage. This is report 2 of 3 for (b)(4). This report is for unknown synthes pedicle screws.
 
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Brand NameUNK - MONO/POLYAXIAL SCREWS: CLICK'X
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 Key9135540
MDR Text Key160692961
Report Number8030965-2019-68849
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeAU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/30/2019
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 Received09/06/2019
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: 09/30/2019 Patient Sequence Number: 1
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