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

Model Number 7510050

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

Patient Problems Nausea (1970); Neuropathy (1983); Pain (1994); Vomiting (2144); Sore Throat (2396); Neck Pain (2433)

Event Date 12/04/2009

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)(4) 2009, patient underwent anterior cervical discectomy and fusion (acdf) levels implanted: c5-c6, c6-c7 -extrapharyngeal anterolateral approach where rhbmp-2 was used.Pre-op diagnosis: degenerative disc disease onset (b)(6) 2009- pain, mild to moderate (in recovery room s/p index surgery).Onset (b)(6) 2009- nausea (in recovery room s/p index surgery.Onset (b)(6) 2009- nausea/vomiting (attributed by patient to narcotic pain medication).Onset (b)(6) 2009- sore throat (attributed by patient to endotracheal tube).Onset (b)(6) 2009-pain, minimal (neck).Onset (b)(6) 2009- "tension", left side of neck radiating to left trapezius.

Event Description

Adverse event 4: onset (b)(6) 2009 - sore throat (attributed by patient to endotracheal tube).Primary diagnosis: sore throat (post-op day#3; attributed by patient to endotracheal tube) relatedness: surgical procedure associated severity: mild; sae: no; outcome: resolved, resolution date: (b)(6) 2009.Adverse event 5: onset (b)(6) 2009 - pain, minimal (neck).Primary diagnosis: pain, minimal (neck) (event occurrence: (b)(6) 2009) relatedness: surgical procedure associated severity: mild; sae: no; outcome: resolved, resolution date: (b)(6) 2010.Adverse event 7: primary diagnosis: "tension", left side of neck radiating to left trapezius (while wearing cervical collar) (event occurrence: (b)(6) 2009) relatedness: not related severity: mild; sae: no; outcome: resolved, resolution date: (b)(6) 2009.

Event Description

It was reported that ae#1 onset (b)(6) 2009.Interscapular pain after acdf surgery.Relatedness: surgical procedure associated.Diagnostic test: no.Surgical treatment: no.Severity: mild.Outcome: resolved, resolution date: (b)(6) 2009.Sae: no.Ae#6 (modified) onset (b)(6) 2009, neck pain after acdf surgery.Diagnostic test: no.Surgical treatment: no.Severity: mild.

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: 5952052
• MDR Text Key: 54749124
• Report Number: 1030489-2016-02552
• 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,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
• Device Expiration Date: 07/31/2010
• Device Model Number: 7510050
• Device Catalogue Number: 7510050
• Device Lot Number: M110901AAH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/18/2016
• Initial Date FDA Received: 09/15/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 10/24/2016
• Supplement Dates FDA Received: 10/07/2016; 11/16/2016; 09/25/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/29/2009
• 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
• Patient Age: 61 YR
• Patient Weight: 119