MAUDE Adverse Event Report: ALLOSOURCE XEMPLIFI DBM PLUS; BONE VOID FILLLER

Model Number 8103.0210S

Device Problems Product Quality Problem (1506); Microbial Contamination of Device (2303)

Patient Problem Bacterial Infection (1735)

Event Date 08/17/2017

Event Type  Injury  

Manufacturer Narrative

According to the report from the distributor, an infection had materialized 3 weeks post surgery.The tissue based medical device is aseptically processed, freeze dried, and terminally sterilized via electron beam irradiation.92 total tissue lots were produced from donor (b)(6): 62 device lots, 19 skin grafts, 2 bone grafts, 9 soft tissue grafts.81 total lots were distributed: 58 device lots were distributed, 4 used as qc samples; all 19 skin lots were distributed; all 2 bone lots were distributed; 2 soft tissue lots were distributed, and 7 were quarantined.Two lots of tissue based device were implanted into the patient associated with this adverse event (b)(4).Allosource has received no additional reports of adverse reactions or adverse events associated with the other 79 distributed lots.91 total tissue lots were produced from donor (b)(6): 54 device lots, 28 skin grafts, 9 soft tissue grafts.77 total lots were distributed: 48 device lots, 4 used as qc samples, 2 discarded prior to distribution; 26 skin lots were distributed, and 2 were quarantined; 3 soft tissue lots were distributed, and 6 were quarantined.One lot of tissue based device was implanted into the patient associated with this adverse event (b)(4).Allosource has received no additional reports of adverse reactions or adverse events associated with the other 76 distributed lots.This report was not submitted on the date prepared for submission due to technical issues with esg.These are the first emdrs to be reported electronically by allosource since initiation of the system, and the individual who had the esg account for submission is no longer with the company.Additionally, the original certificate required to initiate the webtrader account with esg was on a device that was decommissioned and it could not reproduce it.These technical issues were discussed with an individual with the emdr group at cdrh who informed the reporter to place a note in section explaining the technical issues.

Event Description

Three lots of xemplifi dbm plus putty 10cc, from two donors, manufactured by allosource were implanted into a patient on (b)(6) 2017.On (b)(6) 2017 the surgeon notified the private label distributor that he was worried that the patient got a staph infection from the "bone graft".Allosource received notification of the incident on (b)(6) 2017.The three lots of tissue based medical devices remain in the patient.No additional information has been received from the surgeon to date.Three separate adverse event reports are being submitted for the event associated with this patient: 3000215346-2017-00006, 3000215346-2017-00007, 3000215346-2017-00008.

• Brand Name: XEMPLIFI DBM PLUS
• Type of Device: BONE VOID FILLLER
• Manufacturer (Section D): ALLOSOURCE; 6278 s. troy circle; centennial CO 80111
• Manufacturer (Section G): ALLOSOURCE; 6278 s. troy circle; centennial CO 80111
• Manufacturer Contact: trevor wright ; 6278 s. troy circle; centennial, CO 80111 ; 7208734733
• MDR Report Key: 7158022
• MDR Text Key: 96212747
• Report Number: 3000215346-2017-00007
• Device Sequence Number: 1
• Product Code: MBP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 09/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 04/30/2019
• Device Model Number: 8103.0210S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other