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

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

Patient Problem Injury (2348)

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

It was reported that the patient presented with the following pre-operative diagnosis: low back and leg pain syndrome, lumbar spondylosis, previous lumbar discectomy at l1-2.Hypertension, angina pectoris, kidney stones, gastroesophageal reflux.Pre-operatively, imaging evaluations confirmed the presence of significant degenerative change at l1-2.The patient underwent the following procedures: re-exploration of lumbar spine, resection of old skin and subcutaneous scar, internal stabilization from l1 to l2 using a pedicle screw and rod stabilizing system, posterior and lateral mass fusion using autogenous bone plus autologous bone plus bone morphogenic protein, preparation of autogenous bone graft, intraoperative fluoroscopy as per the operative notes, ¿the bone was debrided of attached soft tissue and morcellated for later use as bone graft supplemented with 30 cc of cancellous bone chips rehydrated according to supplier¿s instructions.The facet joint cartilage was resected bilaterally at l1 and l2 and the posterior element cortical bone was burred away at both levels.The bone graft prepared as previously noted was placed over bmp from l1 to l2 on both sides and within the facet joint spaces.¿.No intra-operative complications were reported.

• Brand Name: INFUSE BONE GRAFT
• Type of Device: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 7968492
• MDR Text Key: 123797468
• Report Number: 1030489-2018-01359
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/19/2018
• 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