MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXPEDIUM SPINE SYSTEM DI FAVORED ANGLE REDUCTION SCREW 5.5 X 6 X 40MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	179799640
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation could not be completed; no conclusion could be drawn, as no product was received.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) 2020, that patient underwent revision surgery due to infection and sepsis leading to cage becoming dislodged.Surgeon removed posterior instrumentation, inserted alif cages and put new metalwork in posteriorly in third stage operation.All screws were removed and biopsies taken of the pedicles.No further information provided.This report is for one (1) expedium spine system di favored angle reduction screw 5.5 x 6 x 40mm.This is report 1 of 6 for (b)(4).This (b)(4) will capture the post-op event ( revision was due previous infection and sepsis leading to cage becoming dislodged), while (b)(4) will capture the intra-op event (difficulty removing the s1 screw).
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: b5: additional event information.H11: corrected data.D4: updated.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
Additional event information: it was reported that on (b)(6) 2020, that patient underwent revision surgery due to infection and sepsis leading to cage becoming dislodged.Surgeon removed posterior instrumentation, inserted alif cages and put new metalwork in posteriorly in third stage operation.All screws were removed and biopsies taken of the pedicles.The expedium verse 6 x 50 screw remains implanted.This complaint involves unknown number of devices.
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: 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: EXPEDIUM SPINE SYSTEM DI FAVORED ANGLE REDUCTION SCREW 5.5 X 6 X 40MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9792707
• Report Number: 1526439-2020-00649
• Device Sequence Number: 2574162
• Product Code: KWQ
• UDI-Device Identifier: 10705034083643
• UDI-Public: (01)10705034083643
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: PRE-AMEND
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/10/2020

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: 179799640
• Device Catalogue Number: 199721650
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/10/2020
• Supplement Date Received by Manufacturer: 04/23/2020; 05/06/2020
• Initial Report FDA Received Date: 03/05/2020
• Supplement Report FDA Received Date: 04/30/2020; 05/06/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN CAGE/SPACER; UNKNOWN LOCKING/SET SCREWS; UNKNOWN RODS; UNKNOWN SCREWS
• Outcome Attributed to Adverse Event: Required Intervention