MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE FEN SCR 7.0X45; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	199723745S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
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 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.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, a patient who was eight (8) months post-ops came to the office in (b)(6) 2020.X-rays revealed s1 pedicle screw on right was broken.The patient experienced unspecified adverse event.A revision surgery happened on (b)(6) 2021 due to non-union/broken screw.The procedure and patient outcome were unknown.Concomitant device reported: 5.5 exp verse fen scr 7.0x45 (part# 199723745s, lot# unknown, quantity 2).5.5 exp verse fen scr 7.0x50 (part# 199723750s, lot# unknown, quantity 2).5.5 exp verse unitized set scr (part# 199721001 , lot# unknown, quantity 4).Viper2 lordotic rod-35mm (part# 186788035, lot# unknown, quantity 1).Viper2 lordotic rod-40mm (part#186788040, lot# unknown, quantity 1).This complaint involves one (1) device.This report is for (1) 5.5 exp verse fen scr 7.0x45.This is report 1 of 1 (b)(4).

• Brand Name: 5.5 EXP VERSE FEN SCR 7.0X45
• 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: 11297810
• Report Number: 1526439-2021-00254
• Device Sequence Number: 19767368
• Product Code: NKB
• UDI-Device Identifier: 10705034444505
• UDI-Public: 10705034444505
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K173095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 199723745S
• Device Catalogue Number: 199723745S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2021
• Initial Report FDA Received Date: 02/08/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 37 YR
• Patient Weight: 123