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 199721001

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

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

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.(b)(4).Additional product codes: osh, mnh, kwp, mni, kwq.Complainant part is not expected to be returned for manufacturer review/investigation.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 Description

Device report from synthes reports an event in italy as follows: it was reported the patient experienced a post-operative infection.This is report 11 of 12 for (b)(4).Additional impacted products are captured on related complaint (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.D4: lot number.H4, h6: a manufacturing record evaluation was performed for the finished device: product code: 199721535.Lot number: 300116.It was electronically reviewed and no non-conformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 08/02/2021.Qty: (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.D1: corrected brand name.D4: corrected catalog and udi number.

• Brand Name: 5.5 EXP VERSE SCREW 5.0 X 35
• 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
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 15042756
• MDR Text Key: 296073925
• Report Number: 1526439-2022-01204
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034442464
• UDI-Public: 10705034442464
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K142185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 199721001
• Device Catalogue Number: 199721535
• Device Lot Number: 300116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 5.5 EXP VERSE SCREW 5.0 X 30; 5.5 EXP VERSE SCREW 5.0 X 30; 5.5 EXP VERSE SCREW 5.0 X 30; 5.5 EXP VERSE SCREW 5.0 X 30; 5.5 EXP VERSE SCREW 5.0 X 30; 5.5 EXP VERSE SCREW 5.0 X 30; 5.5 EXP VERSE SCREW 5.0 X 30; 5.5 EXP VERSE SCREW 5.0 X 30; 5.5 EXP VERSE SCREW 5.0 X 30; 5.5 EXP VERSE SCREW 5.0 X 30; 5.5 EXP VERSE SCREW 5.0 X 30; 5.5 EXP VERSE SCREW 5.0 X 30; 5.5 EXP VERSE SCREW 5.0 X 30; 5.5 EXP VERSE SCREW 5.0 X 30; 5.5 EXP VERSE SCREW 5.0 X 30; 5.5 EXP VERSE SCREW 5.0 X 30; 5.5 EXP VERSE UNITIZED SET SCR; 5.5 EXP VERSE UNITIZED SET SCR; 5.5 EXP VERSE UNITIZED SET SCR; 5.5 EXP VERSE UNITIZED SET SCR; 5.5 EXP VERSE UNITIZED SET SCR; 5.5 EXP VERSE UNITIZED SET SCR; 5.5 EXP VERSE UNITIZED SET SCR; 5.5 EXP VERSE UNITIZED SET SCR; 5.5 EXP VERSE UNITIZED SET SCR; ROD, 480 MM; ROD, 480 MM; ROD, 480 MM; ROD, 480 MM; ROD, 480 MM; ROD, 480 MM
• Patient Outcome(s): Required Intervention