MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MIS TI CFX FEN POLY 6X45; ORTHOSIS,PEDICLE SPINAL FIXATION

Model Number	186727645
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	No Code Available (3191); Unspecified Tissue Injury (4559)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is jnj representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; 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 (b)(6) reports an event as follows: it was reported that on an unknown date, the patient underwent for l5-s1 tlif procedure.It was discovered that tpal set were delivered without the applicator instruments.It was unknown when discovered that the applicator shaft is missing.The surgery was completed successfully with 15-20 minutes delay.The patient has infection and pain.This complaint involves an unknown number of devices.This report is for (1) mis ti cfx fen poly 6x45.This is report 1 of 6 for (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.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
As per representative, the device was broke during the surgery.The elliptical handle was broken off.Screws that were delivered incomplete.This complaint involves eleven (11) devices.This (b)(4) captures the 10 out of 11 devices reported/received while (b)(4) captures the other 1 out of 11 devices reported/received.

• Brand Name: MIS TI CFX FEN POLY 6X45
• Common Device Name: ORTHOSIS,PEDICLE SPINAL FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10786208
• Report Number: 1526439-2020-02087
• Device Sequence Number: 2959962
• Product Code: MNI
• UDI-Device Identifier: 10705034282565
• UDI-Public: (01)10705034282565
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K160879
• 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,Followup
• Report Date (Section B): 10/07/2020

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: 186727645
• Device Catalogue Number: 186727645
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/07/2020
• Supplement Date Received by Manufacturer: 12/04/2020
• Initial Report FDA Received Date: 11/04/2020
• Supplement Report FDA Received Date: 12/10/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ELLIPTICAL HANDLE; UNKNOWN KITS/SETS; ELLIPTICAL HANDLE; UNKNOWN KITS/SETS
• Outcome Attributed to Adverse Event: Required Intervention