MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 X 6 X 45MM; ORTHOSIS, SPINAL PEDICLE FIXATION

Model Number	186727645
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
Additional device product codes: pml.Initial reporter address line 1: (b)(6).The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.(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, approximately six (6) months after the initial procedure, the expedium si 6x45mm screw broke.The fracture point of the screw was directly below the screw head, at the transition to the screw shaft.The paravertebral rods were not broken.The patient was initially treated on (b)(6) 2020, with a screw and rod construct on the lumbar spine.On (b)(6) 2021, as part of a revision spondylodesis, the broken screw is replaced with a new screw.All fragments were easily removed.This report involves one (1) viper system fenestrated cortical fix polyaxial screw 5.5 x 6 x 45mm.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).Device history lot: the dhr of product code: 186727645.Lot : 274482.Was electronically reviewed and no non-conformances.Were observed during the manufacturing process.The product was released on: 04.03.2020.Qty: (b)(4).Investigation summary: background: in august 2021, it was reported that on an unknown date, approximately six (6) months after the initial procedure, the expedium si 6x45mm screw broke.The fracture point of the screw was directly below the screw head, at the transition to the screw shaft.The paravertebral rods were not broken.The patient was initially treated on (b)(6) 2020, with a screw and rod construct on the lumbar spine.On (b)(6) 2021, as part of a revision spondylodesis, the broken screw is replaced with a new screw.All fragments were easily removed.This report involves one (1) viper system fenestrated cortical fix polyaxial screw 5.5 x 6 x 45mm.Concomitant device reported: cocr rod (part# 196789480, lot# unknown, quantity 2).Expedium si 5.5 pedicle screws (part# unknown, lot# unknown, quantity 10).Unknown setscrew (part# unknown, lot# unknown, quantity unknown).This complaint involves one (1) device.Investigation flow: damage.Visual inspection: the mis ti cfx fen poly 6x45 (p/n: 179712645, lot number: 274482) was received at us cq along with a photo.Visual inspection of the complaint device showed the shaft of the screw had broken just below the ball head.Device failure/defect was identified.Document/specification review: dwg-1797-12-420/799 rev d (current and manufactured) was reviewed.Dwg-1797-13-620-699 rev b (current and manufactured) was also reviewed.No design issues or discrepancies were identified.Complaint was confirmed.Investigation conclusion: this complaint is confirmed as the shaft of the screw had broken just below the ball head.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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 SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 X 6 X 45MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 11588317
• Report Number: 1526439-2021-00589
• Device Sequence Number: 14220924
• Product Code: MNI
• UDI-Device Identifier: 10705034282565
• UDI-Public: (01)10705034282565
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K160879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2021

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: 186727645
• Device Catalogue Number: 186727645
• Device Lot Number: 274482
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Initial Date Received by Manufacturer: 03/02/2021
• Supplement Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 03/30/2021
• Supplement Report FDA Received Date: 04/16/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EXPEDIUM SI 5.5 PEDICLE SCREWS; SI POLYAXL SCREW 6 X 45MM; UNKNOWN LOCKING/SET SCREWS; VIPER2 STRAIGHT ROD480MM, COCR
• Outcome Attributed to Adverse Event: Required Intervention