MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH CORTICAL FIX X-TAB 6X45MM TI; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	186760145
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Code Available (3191)
Date of Event	10/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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
The primary surgery was performed on (b)(6) 2018 via posterior spine fusion to fix th11-l2 by using ha block (manufacturer was pentax, p/n and lot number were unknown), screws to th11, 12, l1 and l2, and set screws.After the primary surgery on unknown date, the surgeon recognized that the patient suffered the infection.The removal surgery was performed on (b)(6) 2018 to remove the rods, set screws, and the screws at th12 and l1, and the implanted the new screws (p/n and lot number were unknown) to th10 and l3, and then fix with new rods (p/n and lot number were unknown) at th10.11.L2.3 using new set screws (p/n and lot number were unknown).No further information was provided by the hospital.

• Brand Name: CORTICAL FIX X-TAB 6X45MM TI
• 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: 8025700
• Report Number: 1526439-2018-51031
• Device Sequence Number: 11133922
• Product Code: NKB
• UDI-Device Identifier: 10705034465463
• UDI-Public: (01)10705034465463
• Combination Product (Y/N): N
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/22/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: 186760145
• Device Catalogue Number: 186760145
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2018
• Initial Report FDA Received Date: 10/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR