MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MIS CANN POLY SCW 7X45MM,TI; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	186715745
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional device product codes: (b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.(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 the patient underwent minimally invasive surgical (mis) transforaminal lumbar interbody fusion (tlif) procedure on (b)(6) 2019.After 10 days patient developed rashes and itching on his full body.Even after consulting specialist like rheumatologist, immunologist, gastroenterologist, general medicine, at various hospitals, patient is still suffering the same.At present, the patient wants to confirm with the company that it is not because of the materials implanted.Currently there is no plan for any revision surgery.No further information provided this report is for one (1) mis cann poly scw 7x45mm,ti.This is report 4 of 4 for complaint (b)(4).Additional devices are reported under related complaint (b)(4) and (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Product was not returned.Based on the information available, it has been determined that no corrective and 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 history lot the dhr of product code 186715745, lot 247537, was reviewed and no non-conformance was observed during the manufacturing process.The product was released on june 22, 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.H10 additional narrative: updated data: b7 - medical history.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.H6: upon review of the received documents/test results, it does not appear there is a way to conclusively link the test results to an allergic reaction or the implants.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: MIS CANN POLY SCW 7X45MM,TI
• 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: 10819523
• Report Number: 1526439-2020-02151
• Device Sequence Number: 19855320
• Product Code: NKB
• UDI-Device Identifier: 10705034122526
• UDI-Public: (01)10705034122526
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/16/2020

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: 186715745
• Device Catalogue Number: 186715745
• Device Lot Number: 247537
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/16/2020
• Supplement Date Received by Manufacturer: 12/15/2020; 03/02/2021; 05/05/2021
• Initial Report FDA Received Date: 11/10/2020
• Supplement Report FDA Received Date: 12/30/2020; 03/26/2021; 05/19/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention