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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND UNKNOWN_SPINE_PRODUCT; PEDICLE SCREW SPINAL SYSTEM
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STRYKER SPINE-SWITZERLAND UNKNOWN_SPINE_PRODUCT; PEDICLE SCREW SPINAL SYSTEM Back to Search Results
Catalog Number UNK_SPN
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Rash (2033)
Event Date 08/10/2013
Event Type  Injury  
Event Description
It was reported that; the patient underwent spinal surgery on (b)(6) 2013 and was implanted with an oic cage and xia screw and rod fixation.The patient presented recently for an assessment and complained that since she underwent surgery she has allegedly had a persistant rash.The surgeon has queried the composition of the implants, specifically whether there are incipients within the implants that may cause allergic reactions / (rash).
 
Manufacturer Narrative
Device not returned; results: the exact cause of the event could not be determined because the reported device was not returned; therefore the manufacturing records cannot be obtained.This event occurred post-op and the patient observed an allergic reaction after the surgery.Conclusion: the exact cause of the event could not be determined because the reported device was not returned.
 
Event Description
It was reported that; the patient underwent spinal surgery on (b)(6) 2013 and was implanted with an oic cage and xia screw and rod fixation.The patient presented recently for an assessment and complained that since she underwent surgery she has allegedly had a persistant rash.The surgeon has queried the composition of the implants, specifically whether there are incipients within the implants that may cause allergic reactions / (rash).
 
Manufacturer Narrative
Catalog#: 03802060.Method: device not returned; risk assessment; results: a review of the device history records could not be performed as the lot number of the reported device was not provided and it was not returned for identification.It was confirmed, nickel is not present in the xia 3 implants.The referenced risk table indicated; the hazardous situation, "implant with incorrect material used for surgery," as the material was potentially not compatible with the patient, has a severity due to a possible adverse reaction.No new hazard or harm has been identified; conclusion: the xia rod could not be confirmed to cause a rash to the patient.The root cause of the customer reported event could not be determined conclusively.
 
Event Description
It was reported that; the patient underwent spinal surgery on (b)(6) 2013 and was implanted with an oic cage and xia screw and rod fixation.The patient presented recently for an assessment and complained that since she underwent surgery she has allegedly had a persistant rash.The surgeon has queried the composition of the implants, specifically whether there are incipient's within the implants that may cause allergic reactions / (rash).
 
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Brand Name
UNKNOWN_SPINE_PRODUCT
Type of Device
PEDICLE SCREW SPINAL SYSTEM
Manufacturer (Section D)
STRYKER SPINE-SWITZERLAND
le crêt-du-locle 10 a
-
la chaux-de-fonds NJ 2300
CH  2300
Manufacturer (Section G)
STRYKER SPINE-SWITZERLAND
le crêt-du-locle 10 a
-
la chaux-de-fonds NJ 2300
CH   2300
Manufacturer Contact
irma gamonal
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key4537252
MDR Text Key5508359
Report Number3004024955-2015-00012
Device Sequence Number1
Product Code MNI
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 01/29/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Catalogue NumberUNK_SPN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/05/2016
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) Other;
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