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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US UNKNOWN_SPINE_PRODUCT
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STRYKER SPINE-US UNKNOWN_SPINE_PRODUCT Back to Search Results
Catalog Number UNK_SPN
Device Problems Break (1069); Migration or Expulsion of Device (1395); Noise, Audible (3273)
Patient Problem Pain (1994)
Event Date 03/21/2014
Event Type  Injury  
Event Description
It was reported that a xia2 screw breakage (screw thread) in s1 and the surgeon changed the position of v-lift cage.Patient reported pain complaints during recent checkup.The alleged broken screw in s1 was then noticed when checkup pictures were taken.Also it was allegedly noticed by the surgeon that the v-lift was not in its original position anymore.Patient indicated 3 days post-op, when the patient changed position from lying down to sitting up and that she allegedly heard/felt a snap.The patient did not report that to the nurses at that time.
 
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Brand Name
UNKNOWN_SPINE_PRODUCT
Type of Device
UNK
Manufacturer (Section D)
STRYKER SPINE-US
2 pearl court
allendale NJ 07401
Manufacturer (Section G)
STRYKER SPINE-US
2 pearl court
allendale NJ 07401
Manufacturer Contact
daniel roberts
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key3924772
MDR Text Key4520451
Report Number0009617544-2014-00299
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeNL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 06/16/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberUNK_SPN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/16/2014
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? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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