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 Headache (1880); Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Tingling (2171); Dysphasia (2195); Injury (2348); Inadequate Pain Relief (2388); Numbness (2415); Neck Pain (2433)

Event Type  Injury  

Manufacturer Narrative

(b)(6).(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.Products from multiple manufacturers were implanted during the procedure.Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.

Event Description

It was reported that on (b)(6) 2005 the patient underwent: c5-6 and c6-7 anterior cervical discectomy and fusion using spacers and rhbmp-2/acs and cervical instrumentation from c5 to c7 with intraoperative ssep and emg monitoring.Preoperative diagnosis: c5-6 and c6-7 herniated disc and cervical spondylosis.Per-op notes: copious antibiotic irrigation was used.The endplates were then meticulously prepared for fusion.Then 6mm spacers filled with rhbmp-2/acs were tamped into position using fluoroscopic guidance at c5-6 and c6-7.Then a 45mm cervical plate was placed using 13mm screws into the vertebral bodies c5, c6 and c7.On (b)(6) 2005 the patient underwent c5-6, c6-7 anterior cervical discectomy and fusion with spacers and rhbmp-2/acs and instrumentation.Preoperative diagnosis:c5-6, c6-7 herniated nucleus pulpous.On an unknown date post-op patient alleged unspecified injuries due to use of rhbmp-2.

Manufacturer Narrative

(b)(4).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

On (b)(6) 2005, the patient was implanted with rhbmp-2/acs.Allegedly, "patient's post-operative period was marked by a period of improvement, followed by increasingly severe neck pain, headaches, and bilateral shoulder and arm pain and radiculopathy.Patient was experiencing severe and chronic neck pain, with pain radiating to his arms and hands, numbness and tingling in his fingers, swelling in his neck and shoulder area, and limited range of motion in his neck.Patient also experiences difficulty speaking.".

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that on: (b)(6) 2005: the patient was pre-operatively diagnosed with c5-6 and c6-7 herniated disc and cervical spondylosis and underwent the following procedure: c5-6 and c6-7 anterior cervical discectomy and fusion using spacers and bmp and instrumentation from c5 to c7 with intraoperative ssep and emg monitoring.As per op-notes,¿ a c5-6 and c 6-7 anterior cervical diskectomy was undertaken.The posterior longitudinal ligament was removed and bilateral foraminotomies were performed at each level.There was no evidence of csf leak at the completion of the complete discectomy.A blunt book was passed in the cephalad and caudad directions in the central canal without resistance any and out the exiting foramina, bilaterally without any resistance.Copious antibiotic irrigation was used.The endplates were then meticulously prepared for fusion.Then 6-mm cornerstone psr spacers filled with bmp were tamped into position using fluoroscopic guidance at c5-6 and c6-7.Then, a 45- mm plate was placed using 13-mm screws into the vertebral bodies of c5, c6 and c7.¿ the patient tolerated the procedure well without any intraoperative complications.

• 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
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5525246
• MDR Text Key: 41136269
• Report Number: 1030489-2016-00780
• 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,Followup
• Report Date: 12/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2007
• Device Catalogue Number: 7510200
• Device Lot Number: M115002AAC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/11/2017
• 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