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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES (U.S.A.) LP VEPTR II; PROSTHESIS, RIB REPLACEMENT
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SYNTHES (U.S.A.) LP VEPTR II; PROSTHESIS, RIB REPLACEMENT Back to Search Results
Model Number 04.641.079
Device Problem Material Separation (1562)
Patient Problem Insufficient Information (4580)
Event Date 03/01/2021
Event Type  malfunction  
Event Description
The patient came in for an irrigation and debridement of a wound with the possibility of the veptr spine instrumentation having to be removed.An incision was made near the wound and dissected down to the implant and the rods were not together.Part of the one rod was sheared off, the opposite side of the rod was sheared and sticking off of the side.This should have been one piece.Manufacturer response for veptr rod, (brand not provided) (per site reporter).Initial contact: approximately 4 months ago.Response from vendor: asking if it was cleaned through spd.(hospital unable to assure that an implanted device would not contain biohazard material).The next day: hospital requested biohazard return kit to return to vendor for evaluation.(no response).3 days later: hospital requested biohazard return kit to return to vendor for evaluation and asked for internal complaint number.(no response).Approximately 1 month later: hospital requested an update on original request.(no response).Provider requested response from the vendor.(no response).
 
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Brand Name
VEPTR II
Type of Device
PROSTHESIS, RIB REPLACEMENT
Manufacturer (Section D)
SYNTHES (U.S.A.) LP
1210 ward ave
west chester PA 19380
MDR Report Key12158453
MDR Text Key261233013
Report Number12158453
Device Sequence Number1
Product Code MDI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 06/25/2021,05/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number04.641.079
Device Catalogue Number04641079
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/25/2021
Event Location Home
Date Report to Manufacturer07/13/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age5110 DA
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