MAUDE Adverse Event Report: SYNTHES GMBH UNK - CAGE/SPACERS; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 12/01/2022

Event Type  Death  

Event Description

Device report from synthes reports an event in japan as follows: it was reported on (b)(6) 2022, that this pc is related to (b)(4) which report that the patient was infected after the primary surgery.This pc reports that the patient bled out during the revision surgery and passed away after the revision surgery.It was reported that this was a revision surgery performed due to infection on (b)(6) 2022.A plif was performed.The event took place in sequence as follows.1.It was extended to l3 to s.2.A plif (l5 to s) was performed.3.The patient¿s position was changed.Then, cleansing and debridement were performed.4.Posterior fusion was completed without any problems, and bleeding was minimal at that time.After that, the ilium was going to be pinched.The sales rep finished the presence.The sales rep was waiting nearby because there was a possibility of applying posterior compression after the lateral side.5.When the surgeon went to the operating room, bleeding did not stop with lateral approach.The patient was bleeding 2000 ml, and a blood transfusion was performed.The surgery was completed with more than 30 minutes delay.On (b)(6) 2022, the agent reported that the patient passed away.The cause of death is unknown.(b)(4) ¿ unknown screw ¿ reflects infection with debridement.(b)(4) ¿ unknown cage - reflects infection with debridement.(b)(4) ¿ unknown screw ¿ reflects the bleeding and death.(b)(4) ¿ unknown cage ¿ reflects the bleeding and death.No further information is available.This report is for one (1) unk - cage/spacers this is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional narrative: this report is for an unknown cage/spacer/unknown lot.Part and lot numbers are unknown; udi number is unknown.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter occupation is a j&j employee.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNK - CAGE/SPACERS
• Type of Device: INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16188478
• MDR Text Key: 307557238
• Report Number: 8030965-2023-00587
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention