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

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Pain (1994)

Event Date 05/30/2015

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

Primary diagnosis: sacroiliac screw fracture left non union l5-s1 ae of interest: device (implant) displacement.It was reported that on (b)(4) 2015, post op, patient complaint of low back pain recurrence and sacroiliac pain.Patient's previous x-ray and ct scan details were as following: x-ray (abnormal) : sacroiliac screw fracture left ((b)(6) 2011) ct scan (abnormal) : non union l5-s1 sacroiliac screw fracture left ((b)(6) 2011) these diagnosis results revealed that the patient suffered from the following injury: sacroiliac screw fracture left; non union l5-s1.The following actions were taken as a result of the event: in-patient hospitalization: (b)(6) 2012 - conservative care (observation, physiotherapy, education) medications administered (anti-inflammatory, analgesics), medical or non-surgical therapy (waist belt), surgical intervention (new fusion l5-s1).The following assessments were reported in regard of rhbmp-2/acs: investigator assessment: - rhbmp-2/acs relatedness: unknown - study procedure relatedness: related - device/other component relatedness, specify: unknown sponsor assessment: - rhbmp-2/acs relatedness: unknown - study procedure relatedness: related - device/other component relatedness, specify: unknown outcome: -resolved with sequelae (date not provided).

• Brand Name: INDUCTOS
• 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; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 4988407
• MDR Text Key: 22466568
• Report Number: 1030489-2015-01958
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P000058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Other
• Report Date: 07/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/10/2015
• 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: 00049 YR
• Patient Weight: 91