MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 TI CORT FIX 7X40MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	186731740
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Injury (2348); Not Applicable (3189)
Date of Event	03/13/2018
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
On (b)(6) 2014, the spinal surgery was performed.The fixed are was l5-s.On (b)(6) 2018, the reoperation was performed.During the pre-operative meeting, the surgeon planned that the s1 implants would be replaced with l4-5 verse implants after the s1 implants would be removed.When the surgeon checked the x-ray images during the pre-operative meeting, no broken implants were found, the operation was performed after the meeting on the same day (on (b)(6) 2018).As an usual procedure, the expedium l5-s set screws and rods were removed.When the surgeon then tried to remove the reported cortical screws, it was found that the reported cortex screws were broken.The reported cortical screws on both right s1 and left s1 were affected.The surgery was completed with a 60-minute-delay, and there was no adverse consequence to the patient.(this (b)(4) is related to (b)(4).

• Brand Name: 5.5 TI CORT FIX 7X40MM
• 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: 7408163
• Report Number: 1526439-2018-50317
• Device Sequence Number: 16462232
• Product Code: NKB
• UDI-Device Identifier: 10705034352008
• UDI-Public: (01)10705034352008
• Combination Product (Y/N): N
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/13/2018

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: 186731740
• Device Catalogue Number: 186731740
• Device Lot Number: APPN1Y
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/13/2018
• Initial Report FDA Received Date: 04/09/2018
• 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