MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER PRIME CFX XTAB 7X35MM TI; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	186770335S
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Pc: surgical intervention and medical device removal.(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
It was reported that on (b)(6) 2019, after the posterior spine fusion surgery, the surgeon recognized that the screw of the viperprim system was cut out due to the loose tensioning under x-ray.There was less than thirty (30) minutes surgical delay and there was no adverse consequence to the patient.This complaint involves one (1) device.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: VIPER PRIME CFX XTAB 7X35MM TI
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8671822
• Report Number: 1526439-2019-51727
• Device Sequence Number: 2182974
• Product Code: NKB
• UDI-Device Identifier: 10705034530161
• UDI-Public: (01)10705034530161
• Combination Product (Y/N): N
• PMA/510(K) Number: K173095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2019

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: 186770335S
• Device Catalogue Number: 186770335S
• Device Lot Number: TBUGL
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/14/2019
• Supplement Date Received by Manufacturer: 07/22/2019
• Initial Report FDA Received Date: 06/05/2019
• Supplement Report FDA Received Date: 07/22/2019
• 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