MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXP5.5 455MM CONTOUR COCR ROD; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	196791455
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	03/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.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
Surgeon requested hardware removal instruments for (b)(6) 18 revision of a (b)(6) 2017 instrumented case.(b)(6) 2017 case was an extension to and kati get revision,hardware from t3-pelvis.L2 screws were skipped, hardware 455mm pre bent cocr rod broke on patients right side at l2 along with the expedium 5.5 sfx.Surgeon removed verse screws l3-sacro iliac fully threaded sai.Surgeon stated set screws were loose in removal.Surgeon also stated that the formable vivigen was coming out like it went in patient consequence? unknown.Action taken for procedure:surgeon revised construct removing l3-pelvis depuy revised with invasive relign screws and end to end connectors.Is the information being submitted for this complaint all the details that are known/available regarding this event? yes.

• Brand Name: EXP5.5 455MM CONTOUR COCR ROD
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 7393455
• Report Number: 1526439-2018-50299
• Device Sequence Number: 13726877
• Product Code: NKB
• UDI-Device Identifier: 10705034295312
• UDI-Public: (01)10705034295312
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K082942
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/07/2018

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: 196791455
• Device Catalogue Number: 196791455
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/07/2018
• Initial Report FDA Received Date: 04/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Weight: 113