MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC. INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC P

Model Number MSB_UNK_BMP2_ACS

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

Patient Problem Wound Dehiscence (1154)

Event Date 06/28/2021

Event Type  Injury  

Event Description

Information was received from a health care professional via clinical study regarding a patient with clinical id: (b)(6).Primary diagnostic indication: stenosis with documented pre_operative instability from l2-s1.The subject will have treated: 2 levels.Currently consume alcohol, tobacco use ex-user.It was reported that the patient had wound dehiscence.Onset date (b)(6) 2021.  (b)(6) 2021 wound drainage- tx 2wk prophylaxis- keflex;  (b)(6) 2021 cont wound drainage & non healing of upper portion of wound-started patient on bactrim & planned exploratory surgery for (b)(6) 2021;  (b)(6) 2021 admitted for planned exploratory surgery- wound wash out, debridement & wound closured to home (b)(6) 2021.  (b)(6) 2021- (b)(6) visit for incisional leakage of clear yellow drainage, non purulent- nsgy consult- wound oversewn in (b)(6) & pt discharged to home.  (b)(6) 2021 wc- persistant drainage, stitches left in, started bactrim ds for prophylaxis.(b)(6) 2021 wound healed/looks good w/ no sign of infection.Interventions: drug therapy, hospitalization (date of admission: (b)(6) 2021 & date of discharge: (b)(6) 2021), surgical intervention.Length of hospitalization: less than or equal 24h prolongation of existing hospitalization: no there was no patient involvement/symptom reported.There were no further complications reported. outcome status resolved  outcome date (b)(6) 2021 assignment: 4.2 mg of rhbmp-2 randomization date: (b)(6) 2021  number of levels to be treated: 2 levels  pregnant since last visit 6_weeks: has the subject become pregnant since last visit: na date of visit: (b)(6) 2021  pregnant since last visit 3_months: has the subject become pregnant since last visit: na date of visit: (b)(6) 2021 site seriousness assessment: medical intervention: y site related assessment: possible to be related to plf grafting material & surgical procedure and related to surgical construct and/or study procedure.Sponsor assessment: possibly related to infuse kit, mgs kit and casual relationship with surgical procedure.Usade/uade assessment: no could dd have led to sade?: not applicable surgical procedure: date: (b)(6) 2021 treatment group: group 1 - infuse 4.2 + mastergraft + local bone.Updated information received on (b)(6) 2021: additional surgery: procedure date: (b)(6) 2021 describe the additional surgical procedure: wound exploration surgery-wound revision, irrigation, debridement and closure of wound.Index surgery was (b)(6) 2021.Patient was discharged to home on (b)(6) 2021.Levels involved in additional surgical procedure: non-target/non-lumbar level specify the relatedness of the additional surgical procedure to surgical construct and/or the study procedure: related plf grafting material related to surgical construct and/or surgical procedure: possible posterior fixation related to surgical construct and/or surgical procedure: unlikely interbody fusion related to surgical construct and/or surgical procedure: unlikely surgical procedure related to surgical construct and/or surgical procedure: possible.

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.If information is provided in the future, a supplemental report will be issued.

• Brand Name: INFUSE BONE GRAFT
• Type of Device: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC P
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC.; 1800 pyramid place; memphis TN 85281
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC.; 1800 pyramid place; memphis TN 85281
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 12877303
• MDR Text Key: 282609251
• Report Number: 1030489-2021-01462
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MSB_UNK_BMP2_ACS
• Device Catalogue Number: MSB_UNK_BMP2_ACS
• Device Lot Number: MDC4314AAA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2021
• 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): Required Intervention; Hospitalization
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 99 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White