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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - SYNTHES NO FURTHER INFO: SPINE SCREW,FIXATION,BONE

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - SYNTHES NO FURTHER INFO: SPINE SCREW,FIXATION,BONE Back to Search Results
Catalog Number UNK - MISC: SPINE-US
Device Problem Appropriate Term/Code Not Available
Event Type  Injury  
Manufacturer Narrative

This report is for a spine screw. Part and lot numbers are unknown; udi number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. Initial reporter is a company representative. Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. (b)(4). Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
Event Description

It was reported that a johnson & johnson (depuy synthes) employee received a copy of an educational presentation created for an upcoming course for the spine sales team. In the presentation, images of misplaced implanted screws were used for educational purposes. Th images origin is unknown. Patient outcome is unknown. This complaint involves one (1) device. This report is for one (1) unk - screws: spine. This is report 1 of 1 for (b)(4).

 
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Brand NameUNK - SYNTHES NO FURTHER INFO: SPINE
Type of DeviceSCREW,FIXATION,BONE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester , PA 19380
6103142063
MDR Report Key9143685
Report Number2939274-2019-61083
Device Sequence Number1
Product CodeHWC
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 09/10/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/02/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNK - MISC: SPINE-US
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 Received11/05/2019
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?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 10/02/2019 Patient Sequence Number: 1
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