MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER2 LORDOTIC ROD-120MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number 186788120

Device Problem Migration (4003)

Patient Problem No Code Available (3191)

Event Date 10/26/2020

Event Type  Injury  

Manufacturer Narrative

Additional product code kwp; kwq; mnh; mni; osh.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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2020, the patient underwent for a revision surgery.The patient had posterior lumbar interbody fusion (plif) at l3/iliac treating tumor in the sacrum spine on (b)(6) 2020.It was found that on (b)(6) 2020, the rod had come off and setscrews are displaced.It was unknown if the revision surgery successfully completed.The patient outcome was unknown.This complaint involves four (4) devices.This report is for (1) viper2 lordotic rod-120mm.This is report 3 of 4 for (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.H10 additional narrative: 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: VIPER2 LORDOTIC ROD-120MM
• 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: 10868746
• MDR Text Key: 217150945
• Report Number: 1526439-2020-02236
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034131894
• UDI-Public: 10705034131894
• Combination Product (y/n): N
• PMA/PMN Number: K111136
• 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: 10/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 186788120
• Device Catalogue Number: 186788120
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/01/2021
• Patient Sequence Number: 1
• Treatment: 5.5 EXP VERSE UNITIZED SET SCR; MIS SINGLE INNER SETSCW; MIS SINGLE INNER SETSCW; 5.5 EXP VERSE UNITIZED SET SCR; MIS SINGLE INNER SETSCW; MIS SINGLE INNER SETSCW
• Patient Outcome(s): Required Intervention