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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH L-PLATE, LEFT; PLATE, FIXATION, BONE

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STRYKER GMBH L-PLATE, LEFT; PLATE, FIXATION, BONE Back to Search Results
Model Number 40-15091
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Injury (2348); Reaction (2414)
Event Date 12/03/2019
Event Type  Injury  
Manufacturer Narrative
The reported event could be confirmed.A picture of the affected foot was provided.Indeed, black deposits were noticed on the soft tissues especially on the distal part.The l plate as the screws that were implanted with it were returned after decontamination, and do no present any deformation, breakage or such.No deposits can be noticed anymore, since it was decontaminated.In this case, the expertise of a medical expert was requested.They stated the following; "[.] the literature talks about the varying corrosive effects of anodized titanium, relating to the thickness and color of the anodized layers.At a fracture site, wolff¿s law is occurring with a generation of an electrical current, although very slight, the current occurs within the solutions around the plate and soft-tissue and will corrode to metal surface.It is the interaction of an inorganic material in titanium plates, and soft tissue and he degree of roughness of the implant surface, the methods utilized in achieving the surface topography, and the chemistry of implant materials (titanium), are some of the factors that may affect the soft tissue response of the plate to the adjacent soft tissue and create the grayish color.There has been no risk reported with this corrosive action since the levels of local metal ions and systemic ions is usually at very low levels in these cases.In case of high levels of metal ions, risks have been reported associated with local soft tissue damage, delayed hypersensitivity reaction (type iv) and systemic toxicity.[.]" this case can thus be classified as patient factors related.It can be explained by how the patient reacted to the device.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.
 
Event Description
Variax foot plate metallosis noticed upon removal on (b)(6) 2019 by surgeon.Implanted on (b)(6) 2019.Removal not for non-union, just removal of metalware.
 
Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
 
Event Description
Variax foot plate metalosis noticed upon removal on (b)(6) 2019 by surgeon.Implanted on (b)(6) 2019.Removal not for non-union, just removal of metalware.
 
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Brand Name
L-PLATE, LEFT
Type of Device
PLATE, FIXATION, BONE
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH  2545
Manufacturer (Section G)
STRYKER LEIBINGER FREIBURG
boetzingerstr. 41
freiburg D-791 11
DE   D-79111
Manufacturer Contact
sharon rivas
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key9549149
MDR Text Key181811114
Report Number0008031020-2020-00060
Device Sequence Number1
Product Code HRS
UDI-Device Identifier07613154627998
UDI-Public07613154627998
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K063875
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/03/2020
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? No
Device Operator Lay User/Patient
Device Model Number40-15091
Device Catalogue Number40-15091
Device Lot Number1000352948
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/07/2020
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/09/2019
Initial Date FDA Received01/03/2020
Supplement Dates Manufacturer Received02/06/2020
Supplement Dates FDA Received03/03/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/11/2019
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;
Patient Age29 YR
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