MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE CAN SCR 7.0X40; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number 199725740S

Device Problem Device Slipped (1584)

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

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/ investigation.(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

Device report from synthes reports an event in (b)(6) as follows: it was reported that the primary tlif (l5/s1) procedure was performed on (b)(6) 2021 to treat the 5th lumbar spondylolisthesis.The procedure was completed without surgical delay.On an unknown date it was found that the cage had backed out toward the spinal canal.Two screws deployed on both sides of s1 had been quite loose/ wobbly.Also, screw insertions were off the targeted lesion (the screws were supposed to be deployed at the promontorium ossis sacri area).The bone surface (where the loose screws were deployed) had a crack reaching inward.On (b)(6) 2021, the patient underwent the revision procedure.No further information is available.This report is for one (1) 5.5 exp verse can scr 7.0 x 40.This is report 2 of 2 for complaint (b)(4).

• Brand Name: 5.5 EXP VERSE CAN SCR 7.0X40
• 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): SENTIO (INNOVATIVE SURGICAL SOLUTIONS, LLC); 50461 west pontiac trail; wixom MI 48393
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 12634761
• MDR Text Key: 277152950
• Report Number: 1526439-2021-02179
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034440927
• UDI-Public: (01)10705034440927
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 199725740S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2021
• 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
• Patient Outcome(s): Required Intervention