MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXP DI FAR SCREWS 6.00 X 40; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	179799640
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	06/01/2017
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.Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.
Event or Problem Description
It was reported that customer service was contacted by a patient that asked which materials the implants are made of.The patient had spine surgery in (b)(6) 2017.On 30aug2018: per additional information from loc, suspected allergic reaction to expedium screws (lumbar).The patient needs to know what metals compound the titanium alloy.

• Brand Name: EXP DI FAR SCREWS 6.00 X 40
• 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: 7902944
• Report Number: 1526439-2018-50906
• Device Sequence Number: 13801752
• Product Code: NKB
• UDI-Device Identifier: 10705034083643
• UDI-Public: (01)10705034083643
• 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: consumer,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/28/2018

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: 179799640
• Device Catalogue Number: 179799640
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 09/24/2018
• 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: Other