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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL SWIFT-LOCK ANCHOR; SCS ANCHOR
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ABBOTT MEDICAL SWIFT-LOCK ANCHOR; SCS ANCHOR Back to Search Results
Model Number 1192
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pain (1994)
Event Date 11/16/2020
Event Type  Injury  
Manufacturer Narrative
Date of event is estimated.Based on the information provided, a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.
 
Event Description
Related manufacturer reference number: 1627487-2020-48555, 1627487-2020-48554, 1627487-2020-48553.It was reported the patient experienced pain at the anchor site.In turn, the patient underwent surgical intervention on (b)(6) 2020 wherein the anchors were placed deeper to address the issue.It is unknown which anchor is related to the issue.Therefore, all the suspected anchors are being reported.
 
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Brand Name
SWIFT-LOCK ANCHOR
Type of Device
SCS ANCHOR
Manufacturer (Section D)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
MDR Report Key10948578
MDR Text Key219860833
Report Number1627487-2020-48556
Device Sequence Number1
Product Code GZB
UDI-Device Identifier05415067024084
UDI-Public05415067024084
Combination Product (y/n)N
PMA/PMN Number
K092371
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 12/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date06/24/2022
Device Model Number1192
Device Catalogue Number1192
Device Lot Number7552089
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/16/2020
Initial Date FDA Received12/04/2020
Supplement Dates Manufacturer Received12/11/2020
Supplement Dates FDA Received12/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
SCS ANCHOR X3
Patient Outcome(s) Other;
Patient Weight68
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