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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA LP POLYAXIAL SCREW 6.5 X 40MM; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.

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STRYKER SPINE-SWITZERLAND XIA LP POLYAXIAL SCREW 6.5 X 40MM; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS. Back to Search Results
Catalog Number 03821640
Device Problems Biocompatibility (2886); Insufficient Information (3190)
Patient Problems Pain (1994); Reaction (2414)
Event Date 05/20/2016
Event Type  Injury  
Event Description
It was reported that; patient received a posterior lumbar decompression infusion at l4-l5 in (b)(6) 2014.She recently started to experience a lot of aching and pain and her surgeon suggests this may be an allergic reaction to the implant.
 
Manufacturer Narrative
Method: risk assesment; result: device history review could not be performed as no lot code was provided.Device evaluation could not be performed as no items were returned.Complaint history review could not be performed as no lot code was provided.The event could not be confirmed nor the root cause determined because the devices were not returned for evaluation and/or insufficient information was provided for review.Per the ifu; "when hypersensitivity is suspected or proven, it is recommended that the tolerance of the skin to the materials that make up the implants be checked before they are implanted" and "pain, discomfort, or abnormal sensations due to the presence of the device" are known adverse effects and removal may also be recommended in "pain or abnormal sensations due to the presence of the implants.Infection or inflammatory reactions".Conclusion: the exact root cause could not be determined because the devices were not returned for evaluation and/or insufficient information was provided for review.
 
Event Description
It was reported that; patient received a posterior lumbar decompression infusion at l4-l5 in (b)(6) 2014.She recently started to experience a lot of aching and pain and her surgeon suggests this may be an allergic reaction to the implant.
 
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Brand Name
XIA LP POLYAXIAL SCREW 6.5 X 40MM
Type of Device
SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.
Manufacturer (Section D)
STRYKER SPINE-SWITZERLAND
le crêt-du-locle 10 a
-
la chaux-de-fonds 2300
CH  2300
Manufacturer (Section G)
STRYKER SPINE-SWITZERLAND
le crêt-du-locle 10 a
-
la chaux-de-fonds 2300
CH   2300
Manufacturer Contact
rakshya bista
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key5920585
MDR Text Key53678928
Report Number3005525032-2016-00095
Device Sequence Number1
Product Code KWQ
UDI-Device Identifier04546540147257
UDI-Public(01)04546540147257
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K060361
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/20/2016
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 No Information
Device Catalogue Number03821640
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 08/23/2016
Initial Date FDA Received09/01/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received10/17/2016
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;
Patient Age63 YR
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