MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN SCREWS; SCREW,FIXATION,BONE

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

Patient Problem Cardiac Arrest (1762)

Event Date 05/21/2021

Event Type  Death  

Manufacturer Narrative

Additional narrative: 510k: this report is for an unknown screws/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021 the patient underwent surgery for level 4 stabilization of an ankylosing spondylitis using viper cortical fix fenestrated screws and confidence cement.The surgeon used fenestrated screws in the patient bone but stated bone quality was not good and elected to augment with confidence cement.The surgeon used two (2) boxes of cement.A third box was opened but was not used due to change in patient blood pressure.The patient was implanted with the first rod successfully but during the second rod insertion the patient is believed to have gone into cardiac arrest.The patient was implanted with eight (8) screws but one was not tightened in the final rush to remove instrumentation at the end of the case.Toward the end of the procedure, the anesthetist notified the surgeon that the procedure had to be halted immediately due to change in blood pressure.The patient passed away on the table soon after.There is no allegation against the devices that were in use.The surgeon was using the following devices for the procedure: eight (8) unknown screws, eight (8) unknown locking/set screws, two (2) unknown rods, three (3) unknown biomaterial-cement, two (2) unknown attachments, and three (3) unknown biomaterial- cement delivery devices.This report is for one (1) unknown screws.This is report 9 of 26 for (b)(4).

• Brand Name: UNKNOWN SCREWS
• Type of Device: SCREW,FIXATION,BONE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 6103142063
• MDR Report Key: 12018053
• MDR Text Key: 256757430
• Report Number: 1526439-2021-01235
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/21/2021
• 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
• Treatment: UNKNOWN ATTACHMENTS; UNKNOWN ATTACHMENTS; UNKNOWN ATTACHMENTS; UNKNOWN BIOMATERIAL - CEMENT; UNKNOWN BIOMATERIAL - CEMENT; UNKNOWN BIOMATERIAL - CEMENT DELIVERY DEVICES; UNKNOWN BIOMATERIAL - CEMENT DELIVERY DEVICES; UNKNOWN BIOMATERIAL - CEMENT DELIVERY DEVICES; UNKNOWN LOCKING/SET SCREWS; UNKNOWN LOCKING/SET SCREWS; UNKNOWN LOCKING/SET SCREWS; UNKNOWN LOCKING/SET SCREWS; UNKNOWN LOCKING/SET SCREWS; UNKNOWN LOCKING/SET SCREWS; UNKNOWN LOCKING/SET SCREWS; UNKNOWN LOCKING/SET SCREWS; UNKNOWN RODS; UNKNOWN RODS; UNKNOWN SCREWS; UNKNOWN SCREWS; UNKNOWN SCREWS; UNKNOWN SCREWS; UNKNOWN SCREWS; UNKNOWN SCREWS; UNKNOWN SCREWS
• Patient Outcome(s): Death; Required Intervention