MAUDE Adverse Event Report: U&I CORPORATION L'DISQ C; ELECTROSURGICAL DEVICE AND ACCESSORIES

Model Number	PC01
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient is a korean and this incident happened in korea.We have reviewed the device history record (manufacturing & inspection ) of l'disq c.But we cannot find any quality problem in the relevant records.The patient has not felt any pain regarding this problem, and the patient's condition is going to be continuously monitored.As soon as the patient shows his intention on removal surgery, the removal surgery will be performed accordingly.
Event or Problem Description
Procedure was performed on nov 04, 2019 to treat the herniated disk by inserting the device (l'disq c) between c5 and c6 vertebrae.After the disc compression procedure was performed to eliminate the targeted issue of the disc, the surgeon removed the inserted device (l'disq c) from the patient's body to finish the procedure.Then it was confirmed that the part of end tip of the device remained in the patient's body.

• Brand Name: L'DISQ C
• Common Device Name: ELECTROSURGICAL DEVICE AND ACCESSORIES
• Manufacturer (Section D): U&I CORPORATION; 20, sandan-ro, 76beon-gil; uijeongbu, gyeonggi-do, 11781 ; KS 11781
• MDR Report Key: 9345860
• Report Number: 9617297-2019-00004
• Device Sequence Number: 13975649
• Product Code: GEI
• UDI-Device Identifier: 08800015911818
• UDI-Public: 08800015911818
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K132797
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 11/19/2019

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: Health Professional
• Device Expiration Date: 07/21/2021
• Device Model Number: PC01
• Device Lot Number: 19G08008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2019
• Initial Report FDA Received Date: 11/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention