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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH VERTEBRAL BODY STENT-SMALL CEMENT, BONE, VERTEBROPLASTY

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SYNTHES GMBH VERTEBRAL BODY STENT-SMALL CEMENT, BONE, VERTEBROPLASTY Back to Search Results
Catalog Number 09.804.500S
Device Problem Inflation Problem (1310)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2021
Event Type  malfunction  
Manufacturer Narrative
Additional narrative: date of event is an unknown date in 2021. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Reporter is a synthes employee. Device is not distributed in the united states but is similar to device marketed in the usa. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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. 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
Device report from (b)(6) reports an event as follows: it was reported that during a procedure, there was a crack on the stem of the stent that led to a leakage and prevented the stent from expanding. Procedure was completed successfully with no delay. This report is for a vertebral body stent-small. This is report 1 of 1 for (b)(4).
 
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Brand NameVERTEBRAL BODY STENT-SMALL
Type of DeviceCEMENT, BONE, VERTEBROPLASTY
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key11916300
MDR Text Key268248520
Report Number8030965-2021-04459
Device Sequence Number1
Product Code NDN
Combination Product (y/n)N
Reporter Country CodeSN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 05/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number09.804.500S
Device Lot NumberH891418
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/12/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/12/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/18/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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