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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY RAYNHAM 1219655 CANCELLOUS BONE SCREW 6.5X20MM BONE SCREWS AND PINS : SCREWS

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DEPUY RAYNHAM 1219655 CANCELLOUS BONE SCREW 6.5X20MM BONE SCREWS AND PINS : SCREWS Back to Search Results
Catalog Number 117220000
Device Problem Appropriate Term/Code Not Available
Event Date 01/01/2018
Event Type  Injury  
Manufacturer Narrative

(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
Event Description

Revision due to pain.

 
Manufacturer Narrative

(b)(4). Investigation summary: no device associated with this report was received for examination. The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system. Depuy considers the investigation closed. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
Manufacturer Narrative

(b)(4).

 
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Brand NameCANCELLOUS BONE SCREW 6.5X20MM
Type of DeviceBONE SCREWS AND PINS : SCREWS
Manufacturer (Section D)
DEPUY RAYNHAM 1219655
325 paramount dr
raynham MA 02767 0988
Manufacturer (Section G)
JTE RAYNHAM MFG SITE
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester , PA 19380-0988
6103142063
MDR Report Key8167485
Report Number1818910-2018-78329
Device Sequence Number1
Product CodeHWC
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/20/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/15/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number117220000
Device LOT NumberEB2GD4000
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 Received03/06/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/11/2010
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/15/2018 Patient Sequence Number: 1
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