MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK UNKNOWN

Catalog Number MSB_UNK_UNKNOWN

Device Problem Compatibility Problem (2960)

Patient Problem No Code Available (3191)

Event Date 05/12/2015

Event Type  Injury  

Event Description

Type of procedure: posterior lumbar fusion levels implanted: l3-s5 it was reported that a patient underwent plf surgery.Sr understood the patient was implanted with 3dx and the surgery was extension of the last surgery with 3dx, but the implant inside the patient was found out to be 3d and so the surgeon could not remove connectors.The surgeon had to stop and postpone the surgery.Doctor¿s comment: provide information on product compatibility and check surgery history to never make an event like this happen.

Manufacturer Narrative

(b)(4).Neither the device applicable imaging studies were returned to the manufacturer.A definitive cause for this reported event cannot be determined.

Manufacturer Narrative

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

• Brand Name: UNKNOWN
• 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: 4826261
• MDR Text Key: 5842235
• Report Number: 1030489-2015-01142
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,foreign,health professi
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/12/2015

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 Catalogue Number: MSB_UNK_UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/12/2015
• Initial Date FDA Received: 06/09/2015
• Supplement Dates Manufacturer Received: 05/12/2015
• Supplement Dates FDA Received: 09/18/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other