MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC. INFUSE BONE GRAFT/LT-CAGE; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH ME

Lot Number 21AJ

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 12/04/2015

Event Type  malfunction  

Event Description

Patient was lateral, left side up.Doctor stated that the cage broke.Manufacturer response for cage, (brand not provided) (per site reporter): manufacturer to replace device.

• Brand Name: INFUSE BONE GRAFT/LT-CAGE
• Type of Device: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH ME
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC.; 1800 pyramid place; memphis, TN 38132
• MDR Report Key: 5317918
• MDR Text Key: 34099414
• Report Number: 5317918
• Device Sequence Number: 1
• Product Code: OJZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/09/2015,12/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Lot Number: 21AJ
• Other Device ID Number: CDAL PTC 22MM DEG 14X55
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/09/2015
• Event Location: Hospital
• Date Report to Manufacturer: 12/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 59 YR