MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 TI CORT FIX 6X45MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number 186731645

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

Patient Problem Osteolysis (2377)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

Event year is reported as 2021; however exact date of asd development is unknown.Additional device product codes: kwq; mnh; kwp; mni.Complainant part is not expected to be returned for manufacturer review/investigation.A device history record (dhr) review was conducted: a manufacturing record evaluation was performed for the finished device product code: 186731645.Lot number: atmcn3.It was electronically reviewed and no non-conformances /manufacturing irregularities were identified during the manufacturing process.The product was released on: 14.10.2015.Qty: (b)(4).The investigation could not be completed; no conclusion could be drawn, as no product was received.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 on (b)(6) 2016, the patient underwent a primary posterior lumbar interbody fusion (plif) (l4-5) procedure.On (b)(6) 2021, it was reported that the patient had suffered from asd between l3-4.The patient was scheduled to undergo a revision procedure (l3-4 plif extension) on (b)(6) 2021.No further information is available.This report is for one (1) viper system cortical fix polyaxial screw 5.5 6 x 45mm.This is report 11 of 12 for complaint (b)(4).

• Brand Name: 5.5 TI CORT FIX 6X45MM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• 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: 13177275
• MDR Text Key: 288495140
• Report Number: 1526439-2022-00038
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034351834
• UDI-Public: (01)10705034351834
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K110216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,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: 01/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 186731645
• Device Catalogue Number: 186731645
• Device Lot Number: ATMCN3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2005
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 5.5 TI CORT FIX 6X45MM; 5.5 TI CORT FIX 6X45MM; 5.5 TI CORT FIX 6X45MM; CONCORDE BUL PAR 9X8X23; CONCORDE BUL PAR 9X8X23; MMSI ROD, 5.5 X 40MM, TI; MMSI ROD, 5.5 X 40MM, TI; SINGLE-INNER SETSCREW; SINGLE-INNER SETSCREW; SINGLE-INNER SETSCREW; SINGLE-INNER SETSCREW
• Patient Outcome(s): Required Intervention