MAUDE Adverse Event Report: MATRIX SURGICAL USA OMNIPORE® SURGICAL IMPLANT; OMNIPORE® SURGICAL IMPLANT - PETITE PARANASAL

Model Number	OP9520
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Labeling error identified prior to use.No patient involvement reported.Correction taken with recall (b)(4) reported to local regional fda office.Corrective action taken to improve manufacturing process and visibility of this type of labeling error will be reported in recall status reporting.Follow-up report will be submitted if additional information is available.Evaluation: photograph proved by customer with the compliant report confirms the right paranasal (op9520) is in a packaged labeled as op9519 (left).
Event or Problem Description
This report initiated for the "poatienail" that the op9519 petite paranasal - right may be labeled as op9520 petite paranasal - right.On (b)(6) 2019, a physician reported to our (b)(4) distributor that a op9520 petite paranasal - right was labeled as a op9519 petite paranasal - left.The specific reported information from the distributor's email was: "our client claimed the implant (ref: op9519) was not labeled correctly.Op9519 shall be petite paranasal-left, however he found op9519 and op9520 were exact same for paranasal right while opened the sterilized packing".

• Brand Name: OMNIPORE® SURGICAL IMPLANT
• Common Device Name: OMNIPORE® SURGICAL IMPLANT - PETITE PARANASAL
• Manufacturer (Section D): MATRIX SURGICAL USA; 4025 welcome all road; suite 120; atlanta GA 30349 1879
• MDR Report Key: 8362666
• Report Number: 3009383407-2019-00003
• Device Sequence Number: 2034916
• Product Code: KKY
• UDI-Device Identifier: 00855421005871
• UDI-Public: 00855421005871
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K123908
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 02/22/2019

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: 01/06/2022
• Device Model Number: OP9520
• Device Catalogue Number: OP9520
• Device Lot Number: 022050617
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2019
• Initial Report FDA Received Date: 02/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3009383407-01/30/2019
• Patient Sequence Number: 1