MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC P

Model Number 7510050

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

Patient Problem Non-union Bone Fracture (2369)

Event Date 01/03/2022

Event Type  Injury  

Event Description

Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient who had l4-5 olif with posterior percutaneous hardware fixation for degenerative disc disease, spondylitis.Prior history of smoking but had quit 6-10 years prior to surgery it was reported that the patient presents with a non-union at this level after being more than a year post-procedure.  this patient has gone on to non-union for no apparent reason, the surgeon is asking if there was a lot issue with the infuse.Due to the length of time passing between the date of implantation and the date of report, it cannot be determined if there was any issue with the infuse preparation but none was noted.There were no further complications reported regarding the event.

Manufacturer Narrative

Non-union radiographic image review: lateral x-ray and 2 sagittal mri images provided.L4-s1 fusion construct is present.I do not see any retained foreign body as described on the exact report.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 P
• 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: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 13381877
• MDR Text Key: 289203830
• Report Number: 1030489-2022-00075
• Device Sequence Number: 1
• Product Code: NEK
• UDI-Device Identifier: 00613994239518
• UDI-Public: 00613994239518
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/28/2022

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: 08/31/2021
• Device Model Number: 7510050
• Device Catalogue Number: 7510050
• Device Lot Number: MDH4123AAQ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2022
• Initial Date FDA Received: 01/28/2022
• Date Device Manufactured: 11/17/2020
• 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: 39 YR
• Patient Sex: Female
• Patient Weight: 57 KG