MAUDE Adverse Event Report: BACTERIN INTERNATIONAL, INC. OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY; BONE VOID FILLER

Model Number	359100
Medical Device Problem Codes	Labelling, Instructions for Use or Training Problem (1318); Device Markings/Labelling Problem (2911); Inaccurate Information (4051)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A complaint was reported on (b)(6) 2019 indicating that devices containing dbm putty were labeled with a volume of 10.0cc, however, when the pouches were opened for use, the syringes contained 5.0cc of dbm putty.The complainant reported that three devices displaying the same defect had been implanted.There were no reported patient complications with this event.The following mdr submissions are related to this event: 3005031160-2019-00023, 3005031160-2019-00024, 3005031160-2019-00025.The complainant returned three additional devices from the same lot number.Upon opening the foil pouch on one device, it was confirmed that the dbm putty was as described by the complainant.The device was labeled as containing 10.0cc of dbm putty, however, only contained 5.0cc of dbm putty.
Event or Problem Description
A complaint was reported on (b)(6) 2019 indicating that devices containing dbm putty were labeled with a volume of 10.0cc, however, when the pouches were opened for use, the syringes contained 5.0cc of dbm putty.The complainant reported that three devices displaying the same defect had been implanted.The following mdr submissions are related to this event: 3005031160-2019-00023, 3005031160-2019-00024, 3005031160-2019-00025.

• Brand Name: OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY
• Common Device Name: BONE VOID FILLER
• Manufacturer (Section D): BACTERIN INTERNATIONAL, INC.; 664 cruiser lane; belgrade MT 59714
• MDR Report Key: 8592175
• Report Number: 3005031160-2019-00024
• Device Sequence Number: 2010802
• Product Code: MBP
• UDI-Device Identifier: 00849777003681
• UDI-Public: 00849777003681
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K130498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 05/08/2019

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: 06/05/2021
• Device Model Number: 359100
• Device Lot Number: B180228-DBM
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2019
• Initial Report FDA Received Date: 05/08/2019
• 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: Other
• Patient Age: 60 YR
• Patient Weight: 95