MAUDE Adverse Event Report: SYNTHES GMBH 5.5MM TI ROD 200MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 04.633.282

Device Problem Material Integrity Problem (2978)

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

Event Date 03/21/2022

Event Type  Injury  

Event Description

Device report from china reports an event as follows: it was reported that on (b)(6) 2022, a patient underwent internal fixation for spinal fusion.On (b)(6) 2022, it was found in outpatient reexamination that an implanted titanium rod had fractured.On (b)(6) 2022 the rod was removed.This report is for a 5.5mm ti rod 200mm.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Procode: additional procodes: kwp, kwq, mnh, mni.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Device evaluated by mfr and manufacture date: 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: 5.5MM TI ROD 200MM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA ; 3035526892
• MDR Report Key: 14852225
• MDR Text Key: 294918210
• Report Number: 8030965-2022-04446
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034746463
• UDI-Public: (01)10705034746463
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K100952
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 04.633.282
• Device Catalogue Number: 04.633.282
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2022
• 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: UNK PLATE
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR
• Patient Sex: Male