MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

Model Number 7510600

Device Problem Osseointegration Problem (3003)

Patient Problems Fistula (1862); Unspecified Infection (1930); Inadequate Osseointegration (2646)

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

Event Description

Information was received from a literature titled " is reconstruction of large mandibular defects using bioengineering materials effective?" via a manufacturer representative regarding a spinal therapy.It was reported that the retrospective case series and enrolled a sample of patients with mandibular defects that had been reconstructed using allogeneic bone combined with recombinant human bone morphogenic protein-2 and bone marrow aspirate concentrate at our institution during a 5 year period.The success criteria were as follows: bone union, defined as a homogenous radiopaque pattern continuous with native bone with out mandibular mobility; and volume of grafted bone adequate for implant placement, defined as at least 1.0 cm (height) by 0.8 cm (width).Clinical examinations and computed tomography scans were performed at 6 months postoperatively.Descriptive statistics were computed for each variable.From 2014 to 2019, tissue engineering reconstruction was used in 31 patients with and 3 patients without mandibular continuity defects, for a total of 34 patients (19 males and 15 females).The median follow-up was 6 months.The mean length of the continuity defects was 5.5 cm (range, 1.0 to 12.5).Of the 30 patients with mandibular continuity defects, 27 achieved success according to our criteria, with an average gained height of 2.12 ± 0.64 cm and width of 1.53 ± 0.46 cm.Of the 34 patients, 1 was lost to follow-up, and treatment failed in 3 patients.Although the use of autogenous graft remains the reference standard, the evolving science behind clinical tissue engineering has resulted in an effective treatment modality for complex head and neck defects with less morbidity and graft material equal to that of autogenous bone.The postoperative management protocol was as follows: the patient was maintained at npo status with the use of dobhoff feeding tube for 2 weeks.The patient underwent imf for 3 weeks unless contraindicated or the patient was edentulous.A course of antibiotics was given for 7 days after surgery.The development of a perforation or tear within the first 2 weeks results in a greater rate of graft failure.We used local irrigation with peridex and npo noticeable perforation and tears.If noticeable signs of infection were noted (eg, purulence with swelling, abscess formation), the graft was debrided and the soft tissue allowed to heal.The tissue was allowed to heal infection free for at least 3 months before reattempting to graft using an extraoral approach or an immediate composite microvascular flap.The bone graft was allowed to mature for 6 months before placement of dental implants.Of the 34 patients, 15 had been treated with an intraoral approach (14 with immediate reconstruction vs 1 with delayed reconstruction) and 19 with an extraoral approach (8 with immediate reconstruction vs 11 with delayed reconstruction).One patient had undergone delayed reconstruction using a fasciocutaneous free flap with an extraoral approach.The length of stay ranged from 0 to 6 days (average, 2.62 ± 1.75).Patients without medical contraindications and who had agreed were kept in imf for at least 3 weeks.Of the 34 patients, 21 had consented to imf, which remained in place for 22.9 ± 5.0 days.A total of 34 patients (19 males and 15 females) had undergone mandibular reconstruction with 100% tissue engineered graft.All the patients were classified as asa i or ii.The age of the patients ranged from 9 to 89 years old (mean, 37.79 ± 20.4).Of the 31 patients with mandibular discontinuity, 1 had a history of a gunshot wound (gsw) to the face.The remaining 30 cases resulted from pathologic disease.The 30 patients with pathology as the etiology had either undergone resection using a 1-stage approach (n = 19) or a 2-stage approach (n = 11).The gsw patient had undergone a 2-stage approach.The pathologic disease included ameloblastoma in 19, ossifying fibroma in 4, odontogenic keratocyst (okc) in 2, and sclerosing osteomyelitis, odontogenic myxoma, giant cell tumor associated with hyperparathyroidism, and central giant cell granuloma in 1 patient each.One patient had been unsure of the diagnosis that had led to their initial mandibular resection before presenting to our clinic.Of the 3 patients without mandibular discontinuity defects, the pathologic disease was an okc, a glandular odontogenic cyst, and a traumatic bone cyst.All 3 patients had undergone a 1-stage approach.Overall, the length of the defect was 1.0 to 12.5 cm.The average length for the mandibles with and without a discontinuity defect was 5.61 ± 2.92 cm and 4.77 ± 3.33 cm, respectively.Of the 30 patients who had adequate follow-up data available, 27 (90%) achieved successful surgical results according to the criteria previously defined.All 3 patients without continuity defects had successful treatment using our second criterion for success (100%).The average height of bone gained was 2.12 ± 0.44 cm.The average width of bone gained was 1.53 ± 0.55 cm.The quality of bone graft consolidation was determined by the radiopacity of the orthopantomogram during the course of graft maturation.A heterogeneous radiopaque or radiolucent pattern transforming to a homogenous radiopaque pattern on the orthopantomogram is consistent with replacement of allogenic bone with autogenous bone regeneration.Three patients experienced graft failure during the follow-up period.One (b)(6) year-old man with hypertension, elevated cholesterol, diabetes, and a history of stroke presented to the clinic with mucosal dehiscence after an immediate extraoral reconstructive approach.A healthy patient with no significant medical history presented with a cutaneous fistula after an immediate extraoral reconstructive approach.The third patient was a (b)(6) year-old man with a history of depression and bipolar disorder, who sustained a gsw to the face.He fractured his reconstructive plate during another traumatic incident shortly after surgery.The clinical and radiographic follow-up examinations at 6 months postoperatively demonstrated a well-healed and well consolidated volume of bone graft.It is most likely that the local tissues surrounding the grafted site, in addition to the postoperative inflammation process, provide the appropriate inductive signaling molecules for osteomigration and osteodifferentiation.Two failures occurred in our study that resulted from microorganism contamination of the tissue engineered graft.A healthy (b)(6) year-old patient presented with a submandibular infection associated with a draining cutaneous fistula 4 months after immediate reconstruction of his right mandibular discontinuity defect.The second patient was a (b)(6) year-old man with a medical history of recent stroke, diabetes mellitus, and hypertension.He presented with left facial swelling 7 months after resection and reconstruction of a left mandibular ossifying fibroma.The examination showed purulence from intraoral wound dehiscence, and ct of the maxillofacial area displayed signs of graft failure.The patient was taken to the operating room for wound exploration and debridement of the loose bone graft and fibrous tissue.Antibiotics were started appropriately in accordance with the culture result.The postoperative course was complicated by continuing wound dehiscence, and the patient required another formal wound debridement.The third patient, who sustained a gsw to the face, had fractured his reconstructive plate in another traumatic incident shortly after his surgery.It was concluded that these failures had no correlation with the patients medical history because 1 of the 3 patients was completely healthy and the other 2 had vastly different medical conditions.

• Brand Name: INFUSE BONE GRAFT
• Type of Device: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 10709762
• MDR Text Key: 216619152
• Report Number: 1030489-2020-01452
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 7510600
• Device Catalogue Number: 7510600
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/28/2020
• Was Device Evaluated by Manufacturer?: No
• 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; Required Intervention
• Patient Age: 38 YR