MAUDE Adverse Event Report: ALLOSOURCE STRYKER DBM 5 CC GEL; BONE VOID FILLER, PRODICT CODE MBP

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 07/10/2018

Event Type  Injury  

Manufacturer Narrative

Donor (b)(6): 44 total lots were produced from donor (b)(6), 8 soft tissue grafts, and 36 device lots.Twenty six total device lots were distributed and 13 used for qc and validation testing; 3 of the soft tissue grafts were distributed and 5 were quarantined.One lot of tissue-based device was implanted into the patient associated with this adverse event, 170120-6523.Allosource has received no additional reports of adverse reaction or adverse events associated with the other 25 distributed lots.Donor (b)(6): 59 total lots were produced from donor (b)(6), 2 soft tissue grafts, 28 device lots, 17 bone grafts and 11 skin grafts.Twenty four device lots were distributed and 4 were used for qc testing; 2 soft tissue lots were distributed and 1 quarantined.Four bone lots were distributed and 13 were quarantined.All 11 skin lots were distributed.One lot of tissue-based device was implanted into the patient associated with this adverse even, 172132-6511.Allosource has received no additional reports of adverse reactions or adverse events associated with the other 40 distributed lots.On 8/13/2018 allosource quality assurance lab assembly and analysis of all environmental data associated with the donor processing indicates that the clean room environment did not have a negative impact on the quality of the tissue.On 8/22/2018 allosource md review of the donor indicates recovery/preprocessing cultures showed 4 of the 24 grafts positive for propionibacterium acnes the remaining 20 grafts showed no growth, all serologies were negative and the donor met all requirements for processing."on 8/13/81" allosource suitability review indicates that the donor met all release criteria in that all procurement and final cultures were negative or suitable for microbial growth.On 8/13/2018 and 8/14/2013 allosource review of the processing job record and irradiation job record indicates that the lot was processed, cleansed, packaged and irradiated according to procedure.The 2 grafts referenced in report underwent bioburden reduction cleanse and were terminally sterilized with a validated e-beam irradiation process.Additionally, please note that this report is filed late due to many technical difficulties throughout the enrollment process.

Event Description

Two lots of stryker dbm gel 5cc from two different donors, manufactured by allosource were implanted into a patient on (b)(6) 2018.On (b)(6) 2018 the surgeon notified the private label distributor that the patient developed an infection of unknown origin and that the infecting microorganism was unknown.Allosource received notification of the incident on (b)(6) 2018.The 2 lots of tissue based medical device remain in the patient.Additional information received from the surgeon indicated that on (b)(6) 2017, the patient underwent an arthrodosis subtalor joint procedure.On (b)(6) 2017 the patient presented with symptoms; (b)(6) 2017 the patient was readmitted, the surgical wound debrided; cultures taken from the wound site tested positive for enterobacter cloacae.

Event Description

Two lots of stryker dbm gel 5cc from two different donors, manufactured by allosource were implanted into a patient on (b)(6) 2018.On august 1, 2018 the surgeon notified the private label distributor that the patient developed an infection of unknown origin and that the infecting microorganism was unknown.Allosource received notification of the incident on august 2, 2018.The 2 lots of tissue based medical device remain in the patient.Additional information received from the surgeon indicated that on (b)(6) 2017, the patient underwent an arthrodosis subtalor joint procedure.Patient underwent revision surgery on (b)(6) 2018.On (b)(6) 2018 the patient presented with symptoms; 7/24/18 the patient was readmitted, the surgical wound debrided; cultures taken from the wound site tested positive for enterobacter cloacae.

Manufacturer Narrative

Correction section d3 report: d.Suspect medical device manufacturer (allosource) zip code: 80111 correction section b5, report b adverse event or product problem correction as indicated below: two lots of stryker dbm gel 5cc from two different donors, manufactured by allosource were implanted into a patient on (b)(6) 2018.On august 1, 2018 the surgeon notified the private label distributor that the patient developed an infection of unknown origin and that the infecting microorganism was unknown.Allosource received notification of the incident on august 2, 2018.The 2 lots of tissue based medical device remain in the patient.Additional information received from the surgeon indicated that on (b)(6) 2017, the patient underwent an artodosis subtalor joint procedure.Patient underwent revision surgery on 7/1018.On (b)(6) 2018 the patient presented with symptoms; (b)(6) 2018 the patient was readmitted, the surgical wound debrided; cultures taken from the wound site tested positive for enterobacter cloacae.

• Brand Name: STRYKER DBM 5 CC GEL
• Type of Device: BONE VOID FILLER, PRODICT CODE MBP
• Manufacturer (Section D): ALLOSOURCE; 6278 s troy circle; centennial 80111
• MDR Report Key: 7942521
• MDR Text Key: 123071660
• Report Number: 3000215346-2018-00003
• Device Sequence Number: 1
• Product Code: MBP
• Combination Product (y/n): N
• PMA/PMN Number: K071849
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/13/2020
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other