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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 Break (1069)
Patient Problem Inadequate Pain Relief (2388)
Event Date 10/07/2020
Event Type  Injury  
Manufacturer Narrative
Date of event is estimated.The results/method and conclusion codes along with the investigation results will be provided in the final report.
 
Event Description
Device 2 of 2.Reference mfr.Report#: 3006705815-2020-32390.It was reported the patient has been receiving ineffective therapy due to high impedance.Also, x-rays were taken and revealed the patient's anchor to be broken.As a result, the patient may undergo surgical intervention.
 
Manufacturer Narrative
The device history record was reviewed to ensure proper packaging and sterility.Based on the information received, the cause of the reported incident could not be conclusively determined.
 
Event Description
Device 2 of 2.Reference mfr.Report#: (b)(4).
 
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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 Key10764161
MDR Text Key213935488
Report Number1627487-2020-33148
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,foreig
Type of Report Initial,Followup
Report Date 03/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/07/2021
Device Model Number1192
Device Catalogue Number1192
Device Lot Number7241948
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/21/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
MODEL: 3186; MODEL: 3186
Patient Outcome(s) Other;
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