MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE SCREW 4.35 X 30; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	199721430
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Code Available (3191)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product code: kwp, kwq, mnh, mni, osh.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 synthes reports an event in (b)(6) as follows: it was reported on an unknown date that during a removal surgery of a spine construct due to infection on (b)(6) 2020, the surgeon was placed the patient in a brace due to poor bone quality and terminal cancer.The primary surgery was performed on (b)(6) 2020.It was unknown if the removal procedure was completed successfully.The patient outcome was unknown.This complaint involves five (5) devices.This report is for (1) 5.5 exp verse screw 4.35 x 30.This is report 1 of 5 for (b)(4).Related product complaints: (b)(4).
Additional Manufacturer Narrative
Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: b3: event year is reported as 2020; however exact date of event is unknown.E1: updated.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
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H3, h6: customer quality investigation: the implant(s) was not returned, and the investigation will be completed based on the received 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 could not be performed, as the lot number could not be determined from the images provided.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.H11 corrected data: b5: number of parts.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: 5.5 EXP VERSE SCREW 4.35 X 30
• 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: 10192187
• Report Number: 1526439-2020-01260
• Device Sequence Number: 3016387
• Product Code: NKB
• UDI-Device Identifier: 10705034442648
• UDI-Public: 10705034442648
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K142185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/12/2020

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: 199721430
• Device Catalogue Number: 199721430
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/12/2020
• Supplement Date Received by Manufacturer: 06/26/2020; 07/23/2020
• Initial Report FDA Received Date: 06/24/2020
• Supplement Report FDA Received Date: 07/15/2020; 08/11/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DUAL DIAMETER ROD 3.5X5.5, 600.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 3 YR