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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH PROXIMAL LATERAL HUMERUS PLATE AXSOS 3 TI FOR RIGHT HUMERUS 3 HOLE / L86MM; PLATE, FIXATION, BONE
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STRYKER GMBH PROXIMAL LATERAL HUMERUS PLATE AXSOS 3 TI FOR RIGHT HUMERUS 3 HOLE / L86MM; PLATE, FIXATION, BONE Back to Search Results
Catalog Number 627233
Health Effect - Clinical Codes Pain (1994); Foreign Body In Patient (2687)
Date of Event 07/09/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device was disposed.
 
Event or Problem Description
The patient was treated with a axsos phl plate on (b)(6) 2018.The patient complained of pain during her follow-up visit on (b)(6) 2018.Screws of the plate had emigrated.The patient had to be operated again.
 
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Brand Name
PROXIMAL LATERAL HUMERUS PLATE AXSOS 3 TI FOR RIGHT HUMERUS 3 HOLE / L86MM
Common Device Name
PLATE, FIXATION, BONE
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH  2545
MDR Report Key7899269
Report Number0008031020-2018-00622
Device Sequence Number148528
Product Code HRS
UDI-Device Identifier07613327091267
UDI-Public07613327091267
Combination Product (Y/N)N
PMA/510(K) Number
K123964
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 09/21/2018
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
Operator of Device Lay User/Patient
Device Catalogue Number627233
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/27/2018
Initial Report FDA Received Date09/21/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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