MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER PRIME CFX XTAB 7X40MM TI; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	186770340S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional procode: kwp, kwq.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.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 this was a pps in lateral position at l4-5 treating spondylolisthesis on (b)(6) 2021.When the surgeon inserted a screw on the viper prime, the screw idly turned.The surgeon continued the procedure with a replacement stylet and screw.When the surgeon experienced difficulty applying the replacement stylet and screw against the bone, they changed the surgical technique to j-probe+guide wiring and completed insertion.The procedure was completed with less than 30-minute surgical delay.No further information is available.Concomitant medical products: unknown inserter (part# unknown, lot# unknown, quantity unknown).This report is for one (1) viper prime cfx xtab 7x40mm ti.This is report 1 of 1 for (b)(4).

• Brand Name: VIPER PRIME CFX XTAB 7X40MM TI
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 11495299
• Report Number: 1526439-2021-00451
• Device Sequence Number: 19957609
• Product Code: NKB
• UDI-Device Identifier: 10705034530178
• UDI-Public: 10705034530178
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/17/2021

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: 186770340S
• Device Catalogue Number: 186770340S
• Device Lot Number: TBABSG
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2021
• Initial Report FDA Received Date: 03/16/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN INSERTION INSTRUMENTS.; UNKNOWN SCREWDRIVERS.