MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXP5.5 385MM CONTOUR COCR ROD; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	196791385
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without a lot number the device history records review could not be completed.Product was not returned.(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 or Problem Description
It was reported that on (b)(6) 2019, revision surgery was done due to spinal hardware failure, a broken rod on the left side at the region of l5-s1.The broken rod was explanted and replaced.It was initially implanted on (b)(6) 2017.The procedure and patient outcome were unknown.Concomitant device reported: unknown set screws (part# unknown, lot# unknown, quantity unknown).This report is for one (1) exp5.5 385mm contour cocr rod.This is report 1 of 1 for (b)(4).

• Brand Name: EXP5.5 385MM CONTOUR COCR ROD
• 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: 9606647
• Report Number: 1526439-2020-00401
• Device Sequence Number: 524247
• Product Code: NKB
• UDI-Device Identifier: 10705034295305
• UDI-Public: (01)10705034295305
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K082942
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/01/2019

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: 196791385
• Device Catalogue Number: 196791385
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2019
• Initial Report FDA Received Date: 01/20/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR