MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER SYSTEM POLYAXIAL FULLY THREADED SCREW 5.5 8 X 80MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	179706880
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.(b)(4).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, two (2) viper screws broke about 2 cm below the screw head.They had to be replaced during a revision surgery.No further information provided.This report is for one (1) viper system polyaxial fully threaded screw 5.5 8 x 80mm.This is report 1 of 2 for (b)(4).
Event or Problem Description
Device report from synthese reports an event in switzerland as follows: it was reported that on an unknown date, two (2) viper screws broke about 2 cm below the screw head.The patient required revision surgery to have the screws removed.The original date of implantation is unknown.No further information provided.This report is for one (1) viper system polyaxial fully threaded screw 5.5 8 x 80mm.This is report 1 of 2 for (b)(4).

• Brand Name: VIPER SYSTEM POLYAXIAL FULLY THREADED SCREW 5.5 8 X 80MM
• 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: 11365672
• Report Number: 1526439-2021-00347
• Device Sequence Number: 13741000
• Product Code: NKB
• UDI-Device Identifier: 10705034266442
• UDI-Public: (01)10705034266442
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K111571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2021

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: 179706880
• Device Catalogue Number: 179706880
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/02/2021
• Supplement Date Received by Manufacturer: 03/05/2021
• Initial Report FDA Received Date: 02/23/2021
• Supplement Report FDA Received Date: 04/01/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VIPER T27 ILIAC SCREW 8X80, TI; VIPER T27 ILIAC SCREW 8X80, TI
• Outcome Attributed to Adverse Event: Required Intervention