MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE SCREW 5.0 X 35; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	199721535
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Event or Problem Description
Device report from italy reports an event as follows: it was reported that patient underwent revision surgery on (b)(6) 2022, due to infection.Surgical cleaning was performed; no devices were explanted.Patient was originally treated with the expedium verse system on (b)(6) 2022.This report is for a 5.5 exp verse screw 5.0 x 35.This is report 3 of 18 for (b)(4).Additional reports are captured under (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.Additional product codes: kwp, kwq, mnh, mni, osh.Complainant part is not expected to be returned for manufacturer review/investigation.Concomitant devices therapy date is (b)(6) 2022.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.
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: d3 h3, h6: a manufacturing record evaluation was performed for the finished device product code: 199721535 lot number: 309021 it was electronically reviewed and no non-conformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 07/05/2021 the photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned photos.Visual analysis of the photo revealed that there was no damage or defects with the exp verse screw 5.0 x 35 [1997215355.5].There is not enough evidence in the photo to confirm the allegation.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the exp verse screw 5.0 x 35 was found to have no damage or defects.No definitive root cause could be determined.There was no indication that a design or manufacturing issue contributed to the complaint.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 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 5.0 X 35
• 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
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 8472871282
• MDR Report Key: 15502265
• Report Number: 1526439-2022-01704
• Device Sequence Number: 12795395
• Product Code: NKB
• UDI-Device Identifier: 10705034442464
• UDI-Public: (01)10705034442464
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K142185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup

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: 199721535
• Device Catalogue Number: 199721535
• Device Lot Number: 309021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/17/2022
• Supplement Date Received by Manufacturer: 10/10/2022
• Initial Report FDA Received Date: 09/29/2022
• Supplement Report FDA Received Date: 10/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5.5 EXP VERSE SCREW 5.0 X 35; 5.5 EXP VERSE SCREW 5.0 X 35; 5.5 EXP VERSE SCREW 5.0 X 35; 5.5 EXP VERSE SCREW 5.0 X 35; 5.5 EXP VERSE SCREW 5.0 X 35; 5.5 EXP VERSE SCREW 5.0 X 35; 5.5 EXP VERSE SCREW 5.0 X 35; 5.5 EXP VERSE SCREW 5.0 X 35; 5.5 EXP VERSE SCREW 5.0 X 35; 5.5 EXP VERSE SCREW 5.0 X 35; 5.5 EXP VERSE SCREW 5.0 X 35; 5.5 EXP VERSE SCREW 5.0 X 35; 5.5 EXP VERSE SCREW 5.0 X 35; 5.5 EXP VERSE SCREW 5.0 X 35; 5.5 EXP VERSE SCREW 5.0 X 35; 5.5 EXP VERSE SCREW 5.0 X 35; 5.5 EXP VERSE SCREW 5.0 X 35
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown