MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC PRESTIGE LP

Model Number MSB_UNK_PREST_LP

Device Problem Break (1069)

Patient Problem Spinal Column Injury (2081)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from social media via manufacturer representative regarding a device used for spinal therapy.It was reported that the device split into two pieces 6 months after being put between c6/7 vertebrae.No further complications were reported regarding the event.Additional information was received: post-operative diagnosis: postoperative for multilevel cervical disc disease with failure of arthroplasty c6-7 due to broken artificial disc.Surgery performed: anterior cervical approach for removal of broken artificial disc and replacement by stand-alone cage with bone graft c6-7.

• Brand Name: PRESTIGE LP
• 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: 13616836
• MDR Text Key: 286230926
• Report Number: 1030489-2022-00196
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MSB_UNK_PREST_LP
• Device Catalogue Number: MSB_UNK_PREST_LP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/03/2022
• 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): Required Intervention