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

Catalog Number 7510600

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

Patient Problems Ossification (1428); Inflammation (1932); Pain (1994)

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.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.

Event Description

It was reported that on (b)(6) 2008: patient underwent fusion surgery in which rhbmp-2 was used.Per op notes, bmp was placed in confluence l3 to sacral ala bilaterally.An appropriate size peek cage was brought into the surgical field.It was packed with bmp.The cage was then impacted into position at the anterior interdiscal space with excellent end plate contact noted at the l5/s1 level.Appropriate placement was confirmed using intraoperative fluoroscopy.The posterior interdiscal space was then packed with bmp and additional cancellous allograft for a confluent mass.Patient tolerated the procedure well without any intraoperative complications.Patient alleges unspecified injury due to the use of rhbmp-2.

Event Description

It was reported that the patient was subsequently diagnosed with injuries including but not limited to, ectopic bone growth, an inflammatory reaction to rhbmp-2/acs, chronic pain, and additional surgeries.The patient has required extensive medical treatment.Reportedly, the patient has never recovered from her surgery involving rhbmp-2/acs, and she continues to have daily severe disabling pain that prevents her from performing many basic activities of daily living.

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: 5849444
• MDR Text Key: 51224247
• Report Number: 1030489-2016-02282
• 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,Followup
• Report Date: 07/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2010
• Device Catalogue Number: 7510600
• Device Lot Number: M110711AAB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/11/2016
• Initial Date FDA Received: 08/05/2016
• Supplement Dates Manufacturer Received: Not provided; 07/11/2016
• Supplement Dates FDA Received: 08/09/2016; 09/24/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/22/2008
• 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: 82 YR