MAUDE Adverse Event Report: AMPLIFY SURGICAL DUALX; INTERBODY CAGE

Model Number	1283-3007-002
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/19/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Surgeon noticed that direction indicator was flipped with anterior marked on posterior side and posterior marked on anterior side.Surgeon implanted device in correct orientation ignoring incorrect indicator.

• Brand Name: DUALX
• Common Device Name: INTERBODY CAGE
• Manufacturer (Section D): AMPLIFY SURGICAL; 27071 cabot road; suite 118; laguna hills CA 92653
• MDR Report Key: 11682363
• Report Number: 3015255331-2020-01019
• Device Sequence Number: 11552770
• Product Code: MAX
• UDI-Device Identifier: B707128330070020
• UDI-Public: +B707128330070020
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K181397
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/28/2025
• Device Model Number: 1283-3007-002
• Device Catalogue Number: 1282-3007-002
• Device Lot Number: 31934752
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2020
• Initial Report FDA Received Date: 04/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR