MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 TI CORT FIX 7X45MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	186731745
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional product code: kwp; kwq; mnh; mni.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 or Problem Description
It was reported that on an unknown date, the patient had a surgery for posterior spinal fusion in (b)(6) of 2020.At a follow up appointment in (b)(6) of 2020, xray images showed that the set screw had loosened from the sai screws bilaterally and the rod had loosened due to head splay.The s1 and l5 screws had fractured at the neck of the screw just below the tulip.It is unknown if fragments were generated.The patient did not achieve a fusion below l5 due to this hardware failure.Procedure outcome is unknown.This complaint involves five (5) devices.This report is for (1) 5.5 ti cort fix 7x45 mm.This report is 1 of 5 for (b)(4).

• Brand Name: 5.5 TI CORT FIX 7X45MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 12354133
• Report Number: 1526439-2021-01746
• Device Sequence Number: 19938010
• Product Code: NKB
• UDI-Device Identifier: 10705034352015
• UDI-Public: 10705034352015
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 186731745
• Device Catalogue Number: 186731745
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/27/2021
• Supplement Date Received by Manufacturer: 09/22/2021
• Initial Report FDA Received Date: 08/23/2021
• Supplement Report FDA Received Date: 09/22/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5.5 TI CORT FIX 7X45 MM; 5.5 TI CORT FIX 7X45 MM; VIPER TI SAI POLY 9X100 MM; VIPER TI SAI POLY 9X90 MM; 5.5 TI CORT FIX 7X45 MM; 5.5 TI CORT FIX 7X45 MM; VIPER TI SAI POLY 9X100 MM; VIPER TI SAI POLY 9X90 MM
• Outcome Attributed to Adverse Event: Required Intervention