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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND (MDR) XIA ROD DIA. 6 X 70; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
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STRYKER SPINE-SWITZERLAND (MDR) XIA ROD DIA. 6 X 70; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS Back to Search Results
Catalog Number 03802070
Device Problem Break (1069)
Patient Problems Fall (1848); Pain (1994)
Event Date 02/16/2015
Event Type  Injury  
Event Description
It was reported that, the patient fell down and started to complain of pain.It was possible to detect that the rod was broken in the x-ray and magnetic resonance.No permanent or temporary damages in the muscles, bones or neurologic part.Medical intervention reported as yes.
 
Manufacturer Narrative
Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment; results: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Furthermore, it was stated that the patient fell prior to the breakage being discovered.This may have contributed to the event, but this cannot be determined conclusively.Conclusion: the most likely cause of the event is fatigue of the devices due to the length of implantation with the patient's fall possibly contributing to the event.
 
Event Description
It was reported that, the patient fell down and started to complain of pain.It was possible to detect that the rod was broken in the x-ray and magnetic resonance.No permanent or temporary damages in the muscles, bones or neurologic part.Medical intervention reported as yes.
 
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Brand Name
XIA ROD DIA. 6 X 70
Type of Device
SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
Manufacturer (Section D)
STRYKER SPINE-SWITZERLAND (MDR)
le crêt-du-locle 10 a
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la chaux-de-fonds 02300
SZ  02300
Manufacturer (Section G)
STRYKER SPINE-SWITZERLAND (MDR)
le crêt-du-locle 10 a
-
la chaux-de-fonds 02300
SZ   02300
Manufacturer Contact
linford leitch
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key4866923
MDR Text Key6057964
Report Number3005525032-2015-00073
Device Sequence Number1
Product Code KWQ
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K060361
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor,distributor
Reporter Occupation Other
Type of Report Initial
Report Date 05/28/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number03802070
Device Lot NumberSYZ
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/28/2015
Initial Date FDA Received06/24/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/20/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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