MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MIS SINGLE INNER SETSCW; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number 186715000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

Additional product code kwp;kwq;mnh;mni;osh.Complainant part is not expected to be returned for manufacturer review/investigation.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 Description

It was reported that on (b)(6) 2020, the patient presented with issues related to a previous fusion done at (b)(6) hospital in (b)(6) on (b)(6) 2020 and all the hardware was successfully removed.The procedure was an l4-5 right sided tlif with viper prime and conduit plif cultures were taken intra-op for a suspected fungal infection.Procedure and patient outcome are unknown.This complaint involves eleven (11) devices.This report is for (1) mis single inner setscrew.This report is 7 of 10 for (b)(4).

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: the dhr of product code: 186715000, lot : 267922, was electronically reviewed and no non-conformances were observed during the manufacturing process.The product was released on: 10.01.2020, qty: (b)(4).The ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Customer quality investigation: the implant(s) was not returned, and the investigation will be completed based on the supplied image(s).The image(s) was reviewed, and no issues were noted with the implant(s) that would contribute to the adverse event and therefore is unconfirmed.As the implant(s) was not returned an as received, dimensional, material or drawing reviews are not applicable.A manufacturing record evaluation was performed and issues were noted.There is no indication that a design or manufacturing issue contributed to the complaint as it was unconfirmed.No new malfunctions were observed during this investigation (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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.

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.

• Brand Name: MIS SINGLE INNER SETSCW
• Type of Device: 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: 11049244
• MDR Text Key: 226329302
• Report Number: 1526439-2020-02451
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034121192
• UDI-Public: 10705034121192
• Combination Product (y/n): N
• PMA/PMN Number: K160904
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 186715000
• Device Catalogue Number: 186715000
• Device Lot Number: 267922
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/11/2021
• Patient Sequence Number: 1
• Treatment: MIS SINGLE INNER SETSCW; MIS SINGLE INNER SETSCW; POST IBF UI H 13MM 8DEG 22/9; VIPER PRIME X-TAB, 7X40MM TI; VIPER PRIME X-TAB, 7X45MM TI; VIPER PRIME X-TAB, 7X45MM TI; VIPER2 LORDOTIC ROD-45MM; VIPER2 LORDOTIC ROD-45MM
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 95