MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXP 635 TI SI SETSCREW; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	179902000
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional procode: kwp, kwq, mnh, mni, osh.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(4).The investigation could not be completed; no conclusion could be drawn, as no product was received.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 on (b)(6) 2020, the patient underwent a fusion procedure on t11-l3.On (b)(6) 2020, it was reported that the setscrew had come off.A revision procedure was scheduled for (b)(6) 2020.There is no further information available.Concomitant device reported: exp 6.35 ti uni 6 x 45mm (part# 179988645, lot# armcw2, quantity 1), unknown screws (part# unknown, lot# unknown, quantity unknown), unknown rod (part# unknown, lot# unknown, quantity unknown).This report is for one (1) exp 635 ti si setscrew.This is report 1 of 3 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.H3, h4, h6: upon visual inspection there were no issues / damage noted on the implant that would lead to the complaint condition.A definitive root cause for this complaint could not be determined as its unconfirmed.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition.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 history lot, the dhr of product code: 179902000, lot: 260668, was reviewed and no non-conformance was observed during the manufacturing process.The product was released on november 19, 2019.The dhr was electronically reviewed.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.
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.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: EXP 635 TI SI SETSCREW
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10502911
• Report Number: 1526439-2020-01618
• Device Sequence Number: 19596835
• Product Code: NKB
• UDI-Device Identifier: 10705034084664
• UDI-Public: (01)10705034084664
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/11/2020

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: 179902000
• Device Catalogue Number: 179902000
• Device Lot Number: 260668
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2020
• Initial Date Received by Manufacturer: 08/11/2020
• Supplement Date Received by Manufacturer: 09/09/2020; 11/06/2020
• Initial Report FDA Received Date: 09/08/2020
• Supplement Report FDA Received Date: 10/07/2020; 11/06/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EXP 6.35 TI UNI 6 X 45MM.; EXP 635 TI SI SETSCREW.; EXP 635 TI SI SETSCREW.; UNKNOWN RODS.; EXP 6.35 TI UNI 6 X 45MM; EXP 635 TI SI SETSCREW; EXP 635 TI SI SETSCREW; UNKNOWN RODS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 14 YR