MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH ROD, 480 MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number 179762480

Device Problem Device Slipped (1584)

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

Additional procode: kwp; kwq; mnh; mni; osh.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.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

It was reported that on an unknown date, the patient presented with nonunion after being implanted with eight (8) 5.5.Exp verse set screws and two (2) rods.The date of the original surgery is unknown.The patient underwent revision surgery on an unknown date where the surgeon removed the set screws and rods and confirmed they were loose.The patient and procedure outcome are unknown.Concomitant device reported: unknown screw (part# unknown, lot# unknown, quantity unknown).This report is for one (1) rod, 480 mm.This is report 2 of 10 for (b)(4).

• Brand Name: ROD, 480 MM
• 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
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 6103142063
• MDR Report Key: 11528969
• MDR Text Key: 241434777
• Report Number: 1526439-2021-00474
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034077437
• UDI-Public: 10705034077437
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111136
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 179762480
• Device Catalogue Number: 179762480
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Weight: 72