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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 3.7MM TI CERVICAL SPINE SCREW SLF-TPNG/VARIABLE ANGLE 18MM; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, CERVICAL
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OBERDORF SYNTHES PRODUKTIONS GMBH 3.7MM TI CERVICAL SPINE SCREW SLF-TPNG/VARIABLE ANGLE 18MM; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, CERVICAL Back to Search Results
Catalog Number 04.647.878
Device Problem Difficult to Advance (2920)
Patient Problem No Code Available (3191)
Event Date 10/02/2018
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown screw/unknown lot.Part and lot numbers are unknown; udi number is unknown.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.
 
Event Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that during an unknown procedure on (b)(6) 2018, the surgeon attempted to implant the cervical spine screw of the zero-profile variable angle (zero-p va) but it did not progress.Several attempts were made which resulted in the hexagonal part of the screw to be mistreated.The surgeon opted to use a new screw and replaced the punch to break the first cortical which was still unsuccessful.A drill with guide was used to place the screw but it was noted to have slide down with the screw.There was an x-ray image captured during the procedure which showed the screw unable to progress with the head of the screw protruding.A screwdriver was used but, according to the surgeon, it did not have enough space to continue advancing.Another attempt with a double handle screwdriver was used to advance the screw which was unsuccessful.The screw no longer moved forward or backward which is why the surgeon decided to leave it and begin closure.There was a surgical delay of 15-30 minutes reported.The procedure was completed with only two (2) inserted screws since the third screw was already mistreated.The patient status was stable.Concomitant device/s reported: unknown screwdriver (part # unknown, lot unknown, quantity 2), unknown drill bit (part # unknown, lot # unknown, quantity 1), unknown zero-p va implant (part # unknown, lot # unknown, quantity 1), unknown double handle screwdriver (part # unknown, lot # unknown, quantity 1).This report is for one (1) screw, fixation, bone.This is report 2 of 2 for (b)(4).
 
Event Description
This report is for one (1) 3.7mm titanium (ti) cervical spine screw self-tapping.This is report 2 of 3 for (b)(4).
 
Manufacturer Narrative
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.
 
Event Description
Concomitant device/s reported: unknown screwdriver (part # unknown, lot unknown, quantity 1).
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Corrected data: device identification- udi.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.
 
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Brand Name
3.7MM TI CERVICAL SPINE SCREW SLF-TPNG/VARIABLE ANGLE 18MM
Type of Device
INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, CERVICAL
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key7985401
MDR Text Key124479727
Report Number8030965-2018-57469
Device Sequence Number1
Product Code OVE
Combination Product (y/n)N
PMA/PMN Number
K112068
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 10/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number04.647.878
Was Device Available for Evaluation? No
Date Manufacturer Received04/23/2019
Patient Sequence Number1
Treatment
SEE EVENT DESCRIPTION.
Patient Outcome(s) Required Intervention;
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