MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH DI POLYAXL SCREW 8 X 55MM; PEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS

Catalog Number 179722855

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

Patient Problems Osteolysis (2377); Joint Laxity (4526); Insufficient Information (4580)

Event Type  Injury  

Event Description

Device report from synthes reports an event in switzerland as follows: this report is being filed after the review of a clinical evaluation report (cer) from a database related research activity (drra): spine tango soa report - tlif the following complications have been identified: adjacent segment pathology, instability, other.Complication time/intervention.Repeat surgery.This is for depuy synthes spine expedium /other, expedium polyaxial and expedium 5.5 products this is report 3 of 4 for complaint (b)(4).

Manufacturer Narrative

Product complaint (b)(4).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: a1 patient identifier: (b)(6).E3: reporter is a j&j employee.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: without a lot number the device history records review could not be completed.Product was not returned.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.

• Brand Name: DI POLYAXL SCREW 8 X 55MM
• Type of Device: PEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS
• 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: 18464424
• MDR Text Key: 332312396
• Report Number: 1526439-2024-00384
• Device Sequence Number: 1
• Product Code: OSH
• UDI-Device Identifier: 10705034070995
• UDI-Public: (01)10705034070995
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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
• Report Date: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 179722855
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: EXP DUAL-INNER SETSCREW; SI POLYAXL SCREW 7 X 55MM; SINGLE-INNER SETSCREW
• Patient Outcome(s): Required Intervention