MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXP DI FAR SCREWS 7.00 X 55; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number	179799755
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).(b)(4).(01) (b)(4), (11) unknown, (10) (b)(4).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
Hospital: (b)(6).Date: (b(6) 2018.Present in theatre: yes.Name of surgeon: (b)(6).Product codes: (b)(4).Lot numbers - bdhs9sm, om8677, om8574, a11bfb3, ancb16.Impact to patient: revision surgery.Delay in procedure: none.Event details -rods fractured at t12 level and screws broken at l5 level.Revision surgery to replace rods and extend construct to s1 and pelvis.No problems during procedure.Awaiting collection of damaged/removed.
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.Additional narrative: corrected data- description of event or problem, initial reporter name and address.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 united kingdom as follows: it was reported that on an unknown date, the rods fractured at t12 level and screws broken at l5 level.Revision surgery to replace rods and extend construct to s1 and pelvis was performed.No problems during procedure.This is report 3 of 8 for (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).Udi: (b)(4).

• Brand Name: EXP DI FAR SCREWS 7.00 X 55
• 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: 9261790
• Report Number: 1526439-2019-52340
• Device Sequence Number: 2409477
• Product Code: NKB
• UDI-Device Identifier: 10705034083841
• UDI-Public: 10705034083841
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/08/2019

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 Catalogue Number: 179799755
• Device Lot Number: ANBFB3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2019
• Initial Date Received by Manufacturer: 10/08/2019
• Supplement Date Received by Manufacturer: 11/19/2019; 12/11/2019
• Initial Report FDA Received Date: 10/31/2019
• Supplement Report FDA Received Date: 11/21/2019; 12/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention