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 Pain (1994); Loss of Range of Motion (2032); Myalgia (2238); Inadequate Pain Relief (2388); Neck Pain (2433); Neck Stiffness (2434); Sleep Dysfunction (2517)

Event Date 08/22/2011

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 (in a clinical study) that on (b)(6) 2011, patient underwent anterior cervical discectomy and fusion where rhbmp-2 was implanted in the patient at levels: c4-c5, c5-c6, c6-c7.Pre-op diagnosis: acdf for treatment of degenerative disc disease (ddd) procedure: anterior cervical discectomy and fusion (acdf)- extrapharyngeal anterolateral approach.Post-operative, following adverse events were reported.On (b)(6) 2012 the patient was presented for office visit.Primary diagnosis: neck pain.On (b)(6) 2012 the patient was presented for office visit.Primary diagnosis: neck stiffness with worsening neck pain.On (b)(6) 2012 the patient was presented for office visit.Primary diagnosis: could not sleep at night because of worsening neck pain.On (b)(6) 2012 the patient was presented for office visit.Primary diagnosis: limited range of neck motion.

Event Description

It was reported that ae#1: event occurrence: (b)(6) 2011.Primary diagnosis: myalgias (nos).Relatedness: not related.Severity: mild.Sae: no.Ae#2: event occurrence: (b)(6) 2011.Primary diagnosis: muscle weakness (nos).Relatedness: not related.Severity: mild.Sae: no.Outcome: resolved; resolution date: (b)(6) 2011.

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: 5998982
• MDR Text Key: 56443724
• Report Number: 1030489-2016-02753
• 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: study
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/24/2016

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/09/2016
• Initial Date FDA Received: 10/05/2016
• Supplement Dates Manufacturer Received: Not provided; 10/24/2016
• Supplement Dates FDA Received: 11/17/2016; 09/25/2017
• 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: 60 YR
• Patient Weight: 90