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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 Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Implant Pain (4561); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/05/2021
Event Type  Injury  
Manufacturer Narrative
Date of event: date of event is estimated.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
 
Event Description
Related manufacturer report number 1627487-2021-00642.It was reported that the patient had a surgical intervention on (b)(6) 2021 wherein the anchors were repositioned deeper into the patient.
 
Event Description
Additional information indicated that the patient underwent a surgical intervention due to pain at the anchor site.
 
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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 Key11241180
MDR Text Key229084618
Report Number1627487-2021-00681
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
Type of Report Initial,Followup
Report Date 02/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date01/30/2022
Device Model Number1192
Device Catalogue Number1192
Device Lot Number7345391
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received02/02/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
SCS ANCHOR; SCS ANCHOR
Patient Outcome(s) Other;
Patient Weight52
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