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

Catalog Number 7510200

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

Patient Problems Inflammation (1932); Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 that on: (b)(6) 2009: the patient was pre-operatively diagnosed with l3-l4 to l5-s1 disc degeneration with l4-l5 retrolisthesis and underwent the following procedures: l3-l4, l4-l5 and l5-s1 anterior lumbar interbody fusion with instrumentation.L3-l4, l4-l5 and l5-s1 bilateral posterolateral fusion with l3-s1 segmental instrumentation; placement of epidural catheter.As per op-notes, "i ultimately selected a trial spacer with 10 degrees of lordosis, 14 mm in height, 30 mm in depth and 33 mm in width for the l3-l4 space.This peek graft was obtained and filled with a mixture of rhbmp-2 and cancellous allograft bone chips.Small strips of rhbmp-2 and morselized cancellous allograft were placed in the posterior aspect of the disk space.Our peek graft was then impacted into the disc space.Same procedure was repeated at l4-l5 and l5-s1 disc.At l5-s1 level a 14mm height, 10 degree lordotic angled" post-op, patient was diagnosed with ectopic bone growth, an inflammatory reaction to rhbmp-2/acs, chronic pain, and additional surgeries.As a result, patient has required extensive medical treatment.Patient has never recovered from his surgery involving rhbmp-2/acs, and he continues to have daily severe disabling pain that prevents him from performing many basic activities of daily living.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.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: 5976158
• MDR Text Key: 55562351
• Report Number: 1030489-2016-02643
• 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: Attorney
• Type of Report: Initial,Followup
• Report Date: 08/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2011
• Device Catalogue Number: 7510200
• Device Lot Number: M110803AAR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/29/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/21/2009
• 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