MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER PRIME CFXFN XTB 6X45MM S; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number 186760445

Device Problem Migration (4003)

Patient Problems Hematoma (1884); No Code Available (3191)

Event Date 08/14/2020

Event Type  Injury  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(b)(4).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 on unknown date that the patient underwent for 2 level mini-open surgery with viper prime and tlif l4-s1.Due to extreme osteoporotic bone the screw including head of the screw went through the pedicle and exited anterior of the vertebral body, this happened on the right side in l4 as well as s1.On the right side everything went well, the tlif was performed and the rod and innies seated and closed.When it was observed that the screws in l4 and s1 exited anteriorly the surgeon turned on the lateral side, while the aorta and the vena cava, damage observed so far.A small hematoma close to the vena cava was removed.In the same lateral position, the screws securely removed from posterior.The surgery was completed successfully with 240 minutes delay.There were patient consequences with infection and inflammation, etc.Concomitant device reported: unknown innies (part# unknown, lot# unknown, quantity unknown); unknown rod (part# unknown, lot# unknown, quantity unknown).This complaint involves two (2) devices.This report is for (1) viper prime cfxfen xtab 6x45mm.This is report 2 of 2 (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.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: VIPER PRIME CFXFN XTB 6X45MM S
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10517890
• MDR Text Key: 206493875
• Report Number: 1526439-2020-01637
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034509402
• UDI-Public: 10705034509402
• Combination Product (y/n): N
• PMA/PMN Number: K173095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 186760445
• Device Catalogue Number: 186760445S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/05/2020
• Patient Sequence Number: 1
• Treatment: UNKNOWN LOCKING/SET SCREWS; UNKNOWN RODS
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 101