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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SPEEDSET-US FULL DOSE 10 PK BONE CEMENT, ANTIBIOTIC

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STRYKER ORTHOPAEDICS-MAHWAH SPEEDSET-US FULL DOSE 10 PK BONE CEMENT, ANTIBIOTIC Back to Search Results
Catalog Number 61921010
Device Problem Shipping Damage or Problem (1570)
Patient Problem No Patient Involvement (2645)
Event Date 10/20/2016
Event Type  Malfunction  
Manufacturer Narrative

Based on the device identification, the complaint database was reviewed for similar reported events regarding damage. Review of the device history records indicate (b)(4) devices were manufactured and accepted into final stock on (b)(6) 2016 with no reported discrepancies. Lot id: there have been no other events for the lot referenced. An evaluation of the device cannot be performed as the device was not returned to the manufacturer. Should additional information become available it will be reported in a supplemental report upon completion of the investigation. Not returned to manufacturer.

 
Event Description

Hospital receiving department refused case of cement due to damage.

 
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Brand NameSPEEDSET-US FULL DOSE 10 PK
Type of DeviceBONE CEMENT, ANTIBIOTIC
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-LIMERICK
raheen business park
limerick NA
Manufacturer Contact
joann lavatelli
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6603051
MDR Text Key76389762
Report Number0002249697-2017-01743
Device Sequence Number1
Product Code MBB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK063857
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial
Report Date 05/31/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/31/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2018
Device Catalogue Number61921010
Device LOT NumberDFX012
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/05/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/29/2016
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: 05/31/2017 Patient Sequence Number: 1
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