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U.S. Department of Health and Human Services

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

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OBERDORF SYNTHES PRODUKTIONS GMBH SCREW,FIXATION,BONE Back to Search Results
Device Problem Appropriate Term/Code Not Available
Event Type  Injury  
Manufacturer Narrative

Patient information was not provided for reporting. Date of event is unknown. This report is for unknown quantity of unknown screws: zero p. Part#, lot# and udi # is not available. Date of implant is unknown. Date of explant is unknown. Device is not expected to be returned for manufacturer review/investigation. This report is for unknown quantity of unknown screws: zero p. Pma/510(k) number is not available. Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer. Additionally, device history records review could not be completed without lot number. 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) literature article shao et al zero-p. Pdf].

 
Event Description

This report is being filed for the following literature article: s. Hai-yu et al. (2016). A case control of zero profile cervical anterior fusion fixation system and traditional fusion cage plate fixation system for the treatment of single-segmental cervical intervertebral disc herniation. China journal of orthopedic trauma, june 2016, volume 29, number 6. The aim of this study is to compare clinical efficacy of zero profile implant for anterior cervical discectomy and fusion and conventional titanium plate with cage internal fixation for the treatment of single segmental cervical intervertebral disc herniation. From august 2011 to march 2014, clinical data of 139 patients with single cervical disc herniation treated with anterior cervical discectomy and interbody fusion with internal fixation were retrospectively analyzed. The study was comprised of 63 patients in group a which performed anterior discectomy and interbody fusion with zero profile and 76 patients in group b which performed anterior cervical discectomy and cage plate internal fixation. This complaint is reporting the information from group a, as zero p was provided by synthes (b)(4) (b)(6). The following complications were reported: 43 patients experienced postoperative incidences of prevertebral soft tissue thickness. 15 patients experienced postoperative incidences of dysphagia. This report is for an unknown quantity of unknown screws: zero p. This is report 2 of 2 for (b)(4).

 
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Type of DeviceSCREW,FIXATION,BONE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
Manufacturer Contact
michael cote
1302 wright lane east
west chester , PA 19380
6107195000
MDR Report Key7469934
Report Number8030965-2018-53429
Device Sequence Number1
Product CodeHWC
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 04/06/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/27/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
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 Received04/06/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 04/27/2018 Patient Sequence Number: 1
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