MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER2 STRAIGHT ROD300MM, COCR; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	196789300
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional device product code: kwp; kwq; mnh; mni; osh.D10: complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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 (b)(6) 2020, patient underwent t4-l3 pedicle screw fusion with expedium verse of unitized set screws & 300 mm cobalt chrome rods.The patient returned to clinic for postoperative visit complaining of pain in the lumbar spine area.Anterior/posterior (a/p) & lateral x-rays obtained which revealed that the rod was no longer locked in place on the right side at l3 & that the head of the right l3 screw was no longer locked in place.Based on these findings, the surgeon scheduled the patient to return to the or on (b)(6) 2020 for revision of the rod & unitized set screw.After exposure, the surgeon removed the implanted unitized set screw, which was still in the head of the screw but loose, placed the cobalt chrome rod back into the head of the right l3 screw, placed a new unitized set screw, compressed & performed final tightening to the right l3 unitized set screw.He further confirmed rod placement with an a/p x-ray & closed the incision.No further information provided.Concomitant device reported: screw (part# unknown, lot# unknown, quantity unknown);5.5 exp verse unitized set scr (part # 199721001, lot # wl1231, quantity 1).This report is for one (1) 5.5 exp verse unitized set scr.This is report 2 of 2 for (b)(4).

• Brand Name: VIPER2 STRAIGHT ROD300MM, COCR
• 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: 10691292
• Report Number: 1526439-2020-01981
• Device Sequence Number: 3259269
• Product Code: NKB
• UDI-Device Identifier: 10705034295251
• UDI-Public: (01)10705034295251
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K111136
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/24/2020

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: 196789300
• Device Catalogue Number: 196789300
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 10/16/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 16 YR
• Patient Weight: 50