MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXPEDIUM AND VIPER 2 SPINE SYSTEM ROD, STRAIGHT 5.5 X 480MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	196789480
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional device product codes: kwp, osh, mnh, kwq, mni.Complainant part is not expected to be returned for manufacturer review/investigation.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.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 the patient was operated dorsally on the lumbar spine on (b)(6) 2020 due to a subsequent degeneration.It was dorsal spondylodesis with ilium connection on both sides l3 ilium, expedium si & cfx implants, cocr rod.Years ago, due to a scoliotic deformity of the spine, the patient was provided with a long screw-rod stabilization with ventro-lateral access (competitor system, system unknown).On (b)(6) 2020, the patient underwent revision surgery due to a broken cocr rod.The fracture of this rod was noted in the area l5 / left in the area of ¿¿the screw head of the expedition implant.No further information provided.Concomitant device reported: setscrew (part# unknown, lot# unknown, quantity unknown); screw (part# unknown, lot# unknown, quantity unknown).This report is for one (1) expedium and viper 2 spine system rod, straight 5.5 x 480mm.This is report 1 of 1 for complaint (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.A manufacturing record evaluation could not be performed as the lot number could not be determined from the image provided.Customer quality investigation: the complaint device was not received for investigation.The following investigation is based on the image(s) provided.The image(s) was reviewed, and the complaint condition could be confirmed as image shows the device is broken into pieces.Since the device was not returned, a dimensional inspection and a functional test were not able to be performed.A manufacturing record evaluation could not be performed as the lot number could not be determined from the image provided.A definitive assignable root cause could not be determined based on the provided information.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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
Concomitant device reported: rods (part number unknown, lot unknown, quantity 2), screws (part# number unknown, lot unknown, quantity 11).

• Brand Name: EXPEDIUM AND VIPER 2 SPINE SYSTEM ROD, STRAIGHT 5.5 X 480MM
• 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: 11096923
• Report Number: 1526439-2020-02508
• Device Sequence Number: 846696
• Product Code: NKB
• UDI-Device Identifier: 10705034295275
• UDI-Public: (01)10705034295275
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K111136
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• 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): 12/03/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 196789480
• Device Catalogue Number: 196789480
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/03/2020
• Supplement Date Received by Manufacturer: 01/06/2021
• Initial Report FDA Received Date: 12/30/2020
• Supplement Report FDA Received Date: 01/26/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN LOCKING/SET SCREWS; UNKNOWN LOCKING/SET SCREWS; UNKNOWN RODS; UNKNOWN SCREWS; UNKNOWN SCREWS
• Outcome Attributed to Adverse Event: Required Intervention