MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXP 635 TI SI SETSCREW; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	179902000
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 or Problem Description
It was reported that on an unknown date, the patient had a left l5 locking cap back out from and l4-5 fusion with expedium 6.35 back on (b)(6) 2019.The patient has successfully fused and is doing well.There was no need to retrieve the cap or revise the surgery.The procedure outcome is unknown.Concomitant device reported: unknown expedium 6.35 (part# unknown, lot# unknown, quantity unknown); unknown rod (part# unknown, lot# unknown, quantity unknown).This report is for one (1) exp 635 ti si setscrew.This is report 1 of 1 for (b)(4).

• Brand Name: EXP 635 TI SI SETSCREW
• Common Device Name: 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: 10530526
• Report Number: 1526439-2020-01664
• Device Sequence Number: 3336981
• Product Code: NKB
• UDI-Device Identifier: 10705034084664
• UDI-Public: (01)10705034084664
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 179902000
• Device Catalogue Number: 179902000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/17/2020
• Initial Report FDA Received Date: 09/14/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN RODS; UNKNOWN SCREWS
• Patient Weight: 85