MAUDE Adverse Event Report: ABBOTT MEDICAL SWIFT-LOCK ANCHOR; SCS ANCHOR

Model Number 1192

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 02/13/2024

Event Type  Injury  

Event Description

It was reported that the anchor was broken.As a result, surgical intervention was undertaken wherein the anchor was explanted and replaced to address the issue.The investigation was unable to determine the anchor that was broken.

Manufacturer Narrative

B3-date of event is estimated.Reporter phone number- (b)(6).Additional components potentially involved in the event include: common device name: scs anchor: model: 1192 udi: (b)(4), serial: na lot: 8695767.

Event Description

Related manufacturer reference number 1627487-2024-07112.It was reported that the anchor was broken.As a result, surgical intervention was undertaken wherein the anchor was explanted and replaced to address the issue.

• Brand Name: SWIFT-LOCK ANCHOR
• Type of Device: SCS ANCHOR
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer Contact: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 18730967
• MDR Text Key: 335726587
• Report Number: 1627487-2024-07032
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K092371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1192
• Device Lot Number: 8695767
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SCS ANCHOR
• Patient Outcome(s): Other