MAUDE Adverse Event Report: U&I CORPORATION ASPIRON ACP SYSTEM; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Catalog Number	NC3514VD
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The backed out screw was not removed from patient body.No quality problem was found from manufacturing & inspection records of lot 16h216.
Event or Problem Description
It was reported that patient was operated with anterior cervical plate system.A screw in c4 has backed out postoperatively.There were no reports of patient injury.There was no revision surgery to patient.

• Brand Name: ASPIRON ACP SYSTEM
• Common Device Name: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
• Manufacturer (Section D): U&I CORPORATION; 20,sandan-ro,76beon-gil; uijeongbu, gyeonggi-do 11781 ; KS 11781
• MDR Report Key: 7697406
• Report Number: 9617297-2018-00004
• Device Sequence Number: 1451901
• Product Code: KWQ
• UDI-Device Identifier: 08800015909877
• UDI-Public: 08800015909877
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/17/2018

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 Catalogue Number: NC3514VD
• Device Lot Number: 16H216
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2018
• Initial Report FDA Received Date: 07/18/2018
• 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: Other
• Patient Age: 58 YR