MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC DIRECTOSS; BONE GRAFTING MATERIAL

Catalog Number	DXCA251025
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/21/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Per complaint (b)(4), it was reported that bone graft product was mislabeled.The lot number on the label on the box was missing a digit at the end.

• Brand Name: DIRECTOSS
• Common Device Name: BONE GRAFTING MATERIAL
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 8613598
• Report Number: 3001617766-2019-00225
• Device Sequence Number: 16576577
• Product Code: NPM
• UDI-Device Identifier: 10841307122562
• UDI-Public: 10841307122562
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K151209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 05/15/2019

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: Other
• Device Expiration Date: 01/25/2020
• Device Catalogue Number: DXCA251025
• Device Lot Number: IO1809111
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2019
• Initial Report FDA Received Date: 05/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1