MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC 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 Problems Ossification (1428); Incontinence (1928); Neuropathy (1983)

Event Type  Injury  

Manufacturer Narrative

Literature citation: dr.(b)(6) md " pseudo-pedicle heterotopic ossification from rhbmp-2 use in tlif cages." 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.

Event Description

It was reported by in a publication titled " pseudo-pedicle heterotopic ossification from rhbmp-2 use in tlif cages." the purpose of this study was to retrospectively review and describe the common characteristics of patients who developed ho and subsequent radiculopathy from tlifs with rhbmp.Thirty eight patients (26 males and 12 females with a mean age of 50.8 ± 7.5) with radiculopathy symptoms arising from tlif with rhbmp-2 were identified to determine commonalities and defining characteristics that will help facilitate the diagnosis of this complication.All 38 selected patients had radiculopathy symptoms resulting from heterotopic ossification arising out of the intervertebral space in following manner: bone growing out of the annulotomy site for the tlif cage placement was present in continuity with the disc spaces.The common, novel finding was a ¿pseudo-pedicle¿ that appeared as ectopic growth out of the disc space as a solid piece in the same direction as the anatomic pedicle.The radiculopathy symptom development due to ho was independent of the amount of bmp-2 used in tlif.Adverse events: 01 patient has reported radiculopathy, heterotopic ossification, incontinence and bowel symptoms.

Manufacturer Narrative

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 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: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6050153
• MDR Text Key: 58130376
• Report Number: 1030489-2016-02964
• 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: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2016
• 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
• Patient Age: 51 YR