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 Codes	Failure of Implant (1924); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional device product codes: kwp; kwq; mnh; mni.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
Device report from synthes reports an event in (b)(6) as follows: it was reported that the patient underwent the t4-pelvis procedure on (b)(6) 2017.On an unknown postoperative date, the patient had presented to the surgeon with pain and it was identified that the rods broke on both sides at t10 and t11.Patient has a solid fusion.Patient underwent the revision procedure on (b)(6) 2020, where both rods were removed and replaced.No further information is provided.Concomitant device reported: screws (part# unknown, lot# unknown, quantity unknown); locking/set screws (part# unknown, lot# unknown, quantity unknown); rod, 480 mm (part #179762480, lot # unknown, quantity 1).This report is for one (1) exp5.5 385 mm contour cocr rod.This is report 2 of 2 for complaint (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: 10362517
• Report Number: 1526439-2020-01432
• Device Sequence Number: 951577
• Product Code: NKB
• UDI-Device Identifier: 10705034295305
• UDI-Public: (01)10705034295305
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K082942
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/13/2020

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: 196791385
• Device Catalogue Number: 196791385
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2020
• Initial Report FDA Received Date: 08/04/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ROD, 480 MM; UNKNOWN LOCKING/SET SCREWS; UNKNOWN SCREWS
• Outcome Attributed to Adverse Event: Required Intervention