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

Model Number	186770140
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation 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
Further to (b)(4), on (b)(6) 2018, when the patient visited the hospital due to a lower back pain, the breakage of the rod (196789600) was found under the x-ray between l4 and l5 (right), and between l5 and s (left).On (b)(6) 2018, the re-operation was rescheduled due to the patient¿s high crp (c-reactive protein) level.On (b)(6) 2018, the re-operation was performed to find the cause of the patient¿s high crp (c-reactive protein) level, considering the suspected infections.The procedures were conducted in the following way.Screws at l4, l5 and s1 (right) were extracted and new screws were inserted at l5 and s1 to connect with upper rods using a connector.A screw at l5 (left) was extracted to connect with upper rods using a connector.Si set screws at l4 and over (both sides) were replaced with new ones, and rods at far end were also replaced with new ones.Also, the following were commented by the surgeon.Loosening of all the screws were observed when extracted.Torque was not properly applied to si set screws when extracted.Black-colored substances were seen around the screw and the rod, which might have been caused by the metal corrosion.The patient¿s crp level might have increased due to armd caused by the metal corrosion.
Additional Manufacturer Narrative
(b)(4).No product failure was alleged against this device and no failures were observed during evaluation.No root cause analysis is necessary at this time as no product failures have been identified during the course of this investigation.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CORTICAL FIX X-TAB 7X40MM 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: 7736478
• Report Number: 1526439-2018-50721
• Device Sequence Number: 920680
• Product Code: NKB
• UDI-Device Identifier: 10705034465784
• UDI-Public: (01)10705034465784
• Combination Product (Y/N): N
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2018

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: 186770140
• Device Catalogue Number: 186770140
• Device Lot Number: TBJXI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2018
• Initial Date Received by Manufacturer: 07/02/2018
• Supplement Date Received by Manufacturer: 08/23/2018
• Initial Report FDA Received Date: 07/31/2018
• Supplement Report FDA Received Date: 08/24/2018
• 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