MAUDE Adverse Event Report: GRAFTON DBM; BONE GRAFTING MATERIAL, HUMAN SOURCE

Model Number T42275JPN

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

Patient Problem Fluid Discharge (2686)

Event Date 03/19/2021

Event Type  Injury  

Manufacturer Narrative

Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Although it is unknown if the device contributed to the reported event, we are filing this mdr for notification purposes.Manufacturing assessment : the non-conformance database (qn and roar) were reviewed and there were no reported events for the subject batch.Four manufacturing records were reviewed: 1.Rttis-015 router for medcleaning donors that will not yield soft tissue 2.Rttis-019 cartridge mill production of fiber for grafton 3.Rtdbm-019-17 grafton matrix strips reaction router 4.Rtdbm-041-08 matrix strips core packaging router no deviations were observed.Grafton matrix strips test reports were reviewed (base sterility, final product sterility, endotoxin, moisture analysis, glycerol content, calcium assay, environmental monitoring).All tests passed.Hcps reviews based on donor charts: the initial response is that the patient had a post-op infection, however, the additional information revealing that it was determined to be an immune response, not an infection.If it was an immune response, it certainly could be a response to the trauma of the surgery and the immune cells would migrate to the surgical wound.Either way, infection or immune reaction, after reviewing the donor chart and the recovery information, i don¿t believe that our product was responsible for the adverse reaction.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from multiple sources (manufacturer representative, healthcare provider, foreign) regarding a patient with drop head syndrome, anterior and posterior surgery was performed in two stages at c3-6 anterior fixation was performed on (b)(6) (friday) and c2-t1 posterior fixation was performed on (b)(6) (friday).It was reported that after the drain was removed after the operation, the wound swelled, yellow exudate leaked from the inside, and the wound opened.It was said that the yellow exudate had been leaking from the postoperative period to the present.Since this event occurred after discharge, re-hospitalization was required 3 days after discharge.The relationship between the reported event and the use of medtronic product was unknown.There was health damage on the patient.There was no infection and there was an immune response, but the value was not a questionable value from the standard value.The result of the culture was the detection of only resident skin bacteria.The patient took loxonin as a pain reliever after surgery and mucosta to protect the gastric mucosa.For atopic dermatitis, take melex, zolpidem, maprotiline, and pranlukast.Voalla, gentamicin, vitra, tacrolimus, propeto, fenazol, and geben were used as external medicines in ointments.Re-hospitalization and extension of hospitalization period had occurred.(b)(6) 2021 after admission and discharge due to surgery, the patient was readmitted due to this event from (b)(6) 2021 to the present.Patient medical history- atopic dermatitis, shingles, thyroid cyst (thyroid function is normal) date of original discharge: (b)(6) 2021.Exudate from the implanted site.No treatment performed.Readmitted for exudate from (b)(6) 2021 onwards.

• Brand Name: GRAFTON DBM
• Type of Device: BONE GRAFTING MATERIAL, HUMAN SOURCE
• MDR Report Key: 11594014
• MDR Text Key: 260550581
• Report Number: 2246640-2021-00002
• Device Sequence Number: 1
• Product Code: NUN
• Combination Product (y/n): N
• PMA/PMN Number: K051188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/10/2023
• Device Model Number: T42275JPN
• Device Catalogue Number: T42275JPN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/19/2021
• Date Device Manufactured: 11/10/2020
• 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): Hospitalization; Other
• Patient Age: 46 YR
• Patient Weight: 52