MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 7 X 50MM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	186770450S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the stylet could not be removed from the screw.No further information provided.This report is for one (1) viper prime cfx fen x-tab polyaxial screw 5.5 7 x 50mm.This is report 1 of 2 for (b)(4).

• Brand Name: VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 7 X 50MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9943660
• Report Number: 1526439-2020-00841
• Device Sequence Number: 19490217
• Product Code: KWP
• UDI-Device Identifier: 10705034530260
• UDI-Public: (01)10705034530260
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K173095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 186770450S
• Device Catalogue Number: 186770450S
• Device Lot Number: TBWBH
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/13/2020
• Initial Report FDA Received Date: 04/09/2020
• Patient Sequence Number: 1