MAUDE Adverse Event Report: U&I CORPORATION ASPIRON S ACP SYSTEM; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS (KWQ), PRODUCT CODE: KWQ

Model Number	FCA2049
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is an adverse event occured in the united states on (b)(6) 2020.During the surgery with the aspiron s acp system (fca2049), the screw pulled through the plate.The plate was immediately removed from the patient and replaced with a same size product to complete the operation.The product of the issue has been returned, and the dhr(device history record) of it has confirmed that there is no problem.We are currently investigating the specific cause of the issue, and sales of suspension has been notified to us importer until a cause of the issue is figured out.And correction is completed.We will investigate the cause and if there is any further follow-up, it will be reported.
Event or Problem Description
This is an adverse event occured in the united states on (b)(6) 2020.During the surgery with the asperons acp system (fca2049), the screw pulled through the plate.The plate was immediately removed from the patient and replaced with a same size product to complete the operation.

• Brand Name: ASPIRON S ACP SYSTEM
• Common Device Name: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS (KWQ), PRODUCT CODE: KWQ
• Manufacturer (Section D): U&I CORPORATION; 20, sandan-ro, 76beon-gil; uijeongbu, gyeonggi-do 11781 ; KS 11781
• MDR Report Key: 10312000
• Report Number: 9617297-2020-00005
• Device Sequence Number: 2297295
• Product Code: KWQ
• UDI-Device Identifier: 08800037503824
• UDI-Public: (01)08800037503824(11)190824(10)19H12004
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K190053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 07/22/2020

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
• Operator of Device: No Information
• Device Model Number: FCA2049
• Device Catalogue Number: FCA2049
• Device Lot Number: 19H12004
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2020
• Initial Report FDA Received Date: 07/22/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other