MAUDE Adverse Event Report: SYNTHES GMBH UNK - SCREWS: SPINE-US; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Device Problem Material Integrity Problem (2978)

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

Event Type  Injury  

Manufacturer Narrative

Additional narrative: event is post-operative; unknown event date this report is for an unknown spine screw/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported a screw fell apart post-operatively.The patient was diagnosed as "cervical spinal cord injury, cervical lumbar disc herniation and nerve root compression", and underwent the surgery, and implantation of screws on (b)(6) 2022.On the 54th day after operation, the x-ray showed that c3 and c5 screws were fell apart.It is unknown if a revision surgery took place this is report 2 of 2 for (b)(4).This report is for an unknown spine screw.

• Brand Name: UNK - SCREWS: SPINE-US
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14461738
• MDR Text Key: 293535969
• Report Number: 8030965-2022-03339
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNK - SCREWS: SPINE-US
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male