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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BACTERIN INTERNATIONAL, INC. OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY; BONE VOID FILLER
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BACTERIN INTERNATIONAL, INC. OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY; BONE VOID FILLER Back to Search Results
Model Number 359100
Device Problems Labelling, Instructions for Use or Training Problem (1318); Device Markings/Labelling Problem (2911); Inaccurate Information (4051)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/16/2019
Event Type  malfunction  
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 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.
 
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Brand Name
OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY
Type of Device
BONE VOID FILLER
Manufacturer (Section D)
BACTERIN INTERNATIONAL, INC.
664 cruiser lane
belgrade MT 59714
Manufacturer (Section G)
BACTERIN INTERNATIONAL, INC.
664 cruiser lane
belgrade MT 59714
Manufacturer Contact
casey ming
664 cruiser lane
belgrade, MT 59714
4063880480
MDR Report Key8592174
MDR Text Key145638880
Report Number3005031160-2019-00023
Device Sequence Number1
Product Code MBP
UDI-Device Identifier00849777003681
UDI-Public00849777003681
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130498
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Other Health Care Professional
Remedial Action Recall
Type of Report Initial
Report Date 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
Device Operator Health Professional
Device Expiration Date06/05/2021
Device Model Number359100
Device Lot NumberB180228-DBM
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/16/2019
Initial Date FDA Received05/08/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/29/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age60 YR
Patient Weight95
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