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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOBIOLOGICS-MALVERN UNKNOWN_ORTHOBIOLOGICS_PRODUCT; UNKNOWN SPINE PRODUCT
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STRYKER ORTHOBIOLOGICS-MALVERN UNKNOWN_ORTHOBIOLOGICS_PRODUCT; UNKNOWN SPINE PRODUCT Back to Search Results
Catalog Number UNK_ORM
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Pain (1994)
Event Date 02/11/2016
Event Type  Injury  
Event Description
It was reported that patient had a vertebroplasty and since the surgery, she has been experiencing excruciating pain brought on by light movement.Patient wants to know if she has any allergy to the product.Her quality of life has suffered in that she can no longer drive or stand for long periods of time.She is currently seeing another orthopedic surgeon, neuroradiologist, a doctor for pain management/intervention and her primary physician as well as other doctors who she doesn't want to disclose as of yet.Patient asked not to contact her doctors until she speaks with them.
 
Manufacturer Narrative
Method: risk assessment; results: device history, device evaluation, and complaint history review could not be performed as the device was not properly identified.Conclusion: the root cause could not be determined conclusively as no device and/or insufficient information was received.
 
Event Description
It was reported that patient had a vertebroplasty and since the surgery, she has been experiencing excruciating pain brought on by light movement.Patient wants to know if she has any allergy to the product.Her quality of life has suffered in that she can no longer drive or stand for long periods of time.She is currently seeing another orthopedic surgeon, neuroradiologist, a doctor for pain management/intervention and her primary physician as well as other doctors who she doesn't want to disclose as of yet.Patient asked not to contact her doctors until she speaks with them.
 
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Brand Name
UNKNOWN_ORTHOBIOLOGICS_PRODUCT
Type of Device
UNKNOWN SPINE PRODUCT
Manufacturer (Section D)
STRYKER ORTHOBIOLOGICS-MALVERN
45 great valley parkway
malvern PA 19355
Manufacturer (Section G)
STRYKER ORTHOBIOLOGICS-MALVERN
45 great valley parkway
malvern PA 19355
Manufacturer Contact
christa marrow
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key5486233
MDR Text Key39928490
Report Number0002530131-2016-00006
Device Sequence Number1
Product Code NDN
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 02/11/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberUNK_ORM
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received02/11/2016
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
Patient Weight68
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