MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE CAN SCR 6.0X45; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number 199725645S

Device Problem Break (1069)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Device report from (b)(6) reports an event as follows: it was reported that patient underwent revision surgery (plif between l2-sai) on (b)(6) 2022, to treating spinal canal stenosis.It was discovered that a screw deployed at l5 left had broken off.Patient initially underwent the primary procedure (l3-5) to treating spinal canal stenosis on (b)(6) 2020.The revision procedure was completed with no delay.This report is for a 5.5 expedium verse cannulated screw 6.0x45.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Additional narrative: additional procodes: kwp, kwq, mnh, mni, osh.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is a synthes employee.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.(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.

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.A manufacturing record evaluation was performed, for the finished device: product code: 199725645s, lot number#: 262893.It was electronically reviewed, and no non-conformances/ manufacturing irregularities were identified, during the manufacturing process.The product was released on: february 12, 2019.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 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 CAN SCR 6.0X45
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• 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 ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 14102742
• MDR Text Key: 289188727
• Report Number: 1526439-2022-00566
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034440767
• UDI-Public: (01)10705034440767
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K142185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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: 04/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 199725645S
• Device Lot Number: 262893
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention