MAUDE Adverse Event Report: MUSCULOSKELETAL TRANSPLANT FOUNDATION DBX PUTTY, 10CC; FILLER, BONE VOID

Model Number 038100

Device Problem Contamination (1120)

Patient Problem Hepatitis (1897)

Event Date 06/21/2016

Event Type  Injury  

Manufacturer Narrative

Implanted.

Event Description

On 1/27/2017, mtf was notified that a patient of dr.(b)(6) who was implanted with dbx three weeks ago tested (b)(6).

Manufacturer Narrative

All assigned investigation tasks have been completed.There were no patient safety concerns or trends identified; no core gtp violations were noted.The donor and processing batch records for donor (b)(6) were re-reviewed.The donor was appropriately screened and tested in accordance with mtf's donor release criteria.The subject allograft met specification and was appropriately released for distribution and transplantation.The complaint unit was not returned to mtf for evaluation as the graft was implanted.There have been no additional complaints or adverse events received for donor (b)(6).A total of (b)(4) dbx putty units were produced from this donor, all of which have been distributed.There are 25 tissue trace records on file; there is a record on file is for the complaint unit.Environmental data showed that the locations were in control.As per mtf's medical director (dr.(b)(6)), "report of pos (b)(6) test in patient who received dbx implant weeks before.Attempts to get further info on this patient about how long they were known to be pos or what signs and symptoms were present or what risk behaviors were known were unsuccessful.In addition, (b)(6) is widely prevalent to otherwise well patients undergoing surgery.And dbx is highly processed by techniques validated to inactivate viruses including (b)(6).Thus there is no evidence to link the graft to the patient's test result." the investigation is considered closed.

Event Description

On 1/27/2017, mtf was notified that a patient of dr.(b)(6) who was implanted with dbx three weeks ago tested (b)(6).

• Brand Name: DBX PUTTY, 10CC
• Type of Device: FILLER, BONE VOID
• Manufacturer (Section D): MUSCULOSKELETAL TRANSPLANT FOUNDATION; 125 may street; edison NJ 08837
• Manufacturer (Section G): MUSCULOSKELETAL TRANSPLANT FOUNDATION; 125 may street; edison NJ 08837
• Manufacturer Contact: mary agostisi ; 125 may street; edison, NJ 08837 ; 7326613160
• MDR Report Key: 6365389
• MDR Text Key: 68550494
• Report Number: 2249062-2017-00001
• Device Sequence Number: 1
• Product Code: MBP
• Combination Product (y/n): N
• PMA/PMN Number: K040262
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 01/21/2018
• Device Model Number: 038100
• Device Catalogue Number: 038100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/27/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/02/2016
• 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
• Patient Age: 60 YR