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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH CROSS PLATE LAPIDUS STEP, RT ANCHORAGE PLATE, FIXATION, BONE

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STRYKER GMBH CROSS PLATE LAPIDUS STEP, RT ANCHORAGE PLATE, FIXATION, BONE Back to Search Results
Catalog Number PLP29372S
Device Problems Misconnection (1399); Difficult to Advance (2920)
Patient Problem No Information (3190)
Event Date 10/27/2017
Event Type  Malfunction  
Manufacturer Narrative

Device will not be returned. If additional information becomes available it will be provided on a supplemental report. Disposition unknown.

 
Event Description

Issue with screw head going through the plates and not engaging.

 
Manufacturer Narrative

This device is concomitant and did not contribute to the reported failure. This investigation is therefore closed in phase 1. If any additional information is provided indicating otherwise the record will be reopened and the investigation will be reworked.

 
Event Description

Issue with screw head going through the plates and not engaging.

 
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Brand NameCROSS PLATE LAPIDUS STEP, RT ANCHORAGE
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH 2545
Manufacturer (Section G)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH 2545
Manufacturer Contact
rose haas
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key7041006
MDR Text Key93139507
Report Number0008031020-2017-00661
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeGB
PMA/PMN NumberK083447
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/19/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/17/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberPLP29372S
Device LOT NumberV07750
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/27/2017
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 TREATMENT DATA
Date Received: 11/17/2017 Patient Sequence Number: 1
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