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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655 CANCELLOUS BONE SCREW 6.5X50MM BONE SCREWS AND PINS : SCREWS

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DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655 CANCELLOUS BONE SCREW 6.5X50MM BONE SCREWS AND PINS : SCREWS Back to Search Results
Catalog Number 117250000
Device Problem Appropriate Term/Code Not Available
Event Type  Injury  
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. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary. (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

Ppf and sticker sheets received. Ppf alleges infection requiring iv antibiotics.

 
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Brand NameCANCELLOUS BONE SCREW 6.5X50MM
Type of DeviceBONE SCREWS AND PINS : SCREWS
Manufacturer (Section D)
DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655
325 paramount drive
raynham MA 02767
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-XXXX
6107428552
MDR Report Key8090183
Report Number1818910-2018-76064
Device Sequence Number1
Product CodeHWC
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
Type of Report Initial
Report Date 10/29/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/20/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number117250000
Device LOT NumberU2RBT1000
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/29/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/10/2000
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: 11/20/2018 Patient Sequence Number: 1
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