MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN RODS; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Device Problem Device Slipped (1584)

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

Event Date 01/01/2022

Event Type  Injury  

Manufacturer Narrative

Additional narrative: 510k: this report is for an unknown rod/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.510k: this report is for an unknown rod/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Reporter is a j&j sales representative.(b)(4).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

It was reported that on an (b)(6) 2022 ,the patient underwent revision surgery due to loosening of rod/set screw.The rod loosens within the tulip head.Patient and procedure outcome were unknown.This report is related to (b)(4) which captures the reported event of patient requiring 3rd surgery as the rod has once again migrated in the tulip head.This is report 3 of 3 for (b)(4).

• Brand Name: UNKNOWN RODS
• 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: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 13896056
• MDR Text Key: 289973571
• Report Number: 1526439-2022-00453
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• 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: 03/24/2022
• 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: 02/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 5.5 EXP VERSE SCREW 8.0 X 50; 5.5 EXP VERSE UNITIZED SET SCR
• Patient Outcome(s): Required Intervention