MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER TI SAI POLY 8X70MM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	179704870
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Injury (2348)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter is synthes sales representative.Without a lot number the device history records review could not be completed.Product was not returned.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 (b)(6) 2015, an initial spinal fusion was performed for kyphosis.The procedure was for building construct in t9-s2.On (b)(6) 2015, a second procedure was performed for osteotomy in l1 and re-deploying the devices stryker¿s connector and rod which were implanted in the initial procedure.The implanted rod was connected to the stryker¿s connector.On (b)(6) 2018, the revision procedure was performed for an unknown reason.The surgeon explanted two (2) unknown expedium screws in s1 and replaced them with unknown screws.Also, one (1) screw was replaced in s2 left, s2 right.One (1) rod was explanted and replaced with two (2) rods connected to the stryker¿s connector.No further information is available.Concomitant device reported: unknown set screws (part# unknown, lot# unknown, quantity unknown); viper ti sai poly 8x70mm (part# 179704870, lot# unknown, quantity 1); rod, 480 mm (part# 179762480, lot# unknown, quantity 1); unknown locking/set screws (part# unknown, lot# unknown, quantity unknown).This complaint is related to (b)(4) which involves four total procedures ((b)(6) 2015, (b)(6) 2015, (b)(6) 2018, (b)(6) 2020).This report is for one (1) viper ti sai poly 8x70mm.This is report 2 of 5 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.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.

• Brand Name: VIPER TI SAI POLY 8X70MM
• 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: 10176443
• Report Number: 1526439-2020-01211
• Device Sequence Number: 3083379
• Product Code: KWP
• UDI-Device Identifier: 10705034265704
• UDI-Public: (01)10705034265704
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2020

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: 179704870
• Device Catalogue Number: 179704870
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/01/2020
• Supplement Date Received by Manufacturer: 07/08/2020
• Initial Report FDA Received Date: 06/19/2020
• Supplement Report FDA Received Date: 07/08/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ROD, 480 MM; UNKNOWN LOCKING/SET SCREWS; UNKNOWN SCREWS; UNKNOWN SCREWS; VIPER TI SAI POLY 8X70MM
• Outcome Attributed to Adverse Event: Required Intervention