MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXP 635 TI SI SETSCREW; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number 179902000

Device Problem Unintended Movement (3026)

Patient Problem No Code Available (3191)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Upon visual inspection, no damage was noted on the implant.Based on the review of the above drawings, no design issues contributing to relevant complaint condition were identified.A definitive root cause for this complaint as its unconfirmed.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot: part number: 179902000, lot number: 258323.Release to warehouse date: october 25, 2019.Qty.(b)(4).A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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 on (b)(6) 2020, the patient had a posterior lumbar decompression and fusion at l2-5 on (b)(6) 2020.On (b)(6) 2020, patient heard a ¿pop¿ sound and experienced an increase in pain at the surgical site.Imaging on (b)(6) 2020 confirmed that the locking cap of the left l2 screw had disengaged from the tulip of the pedicle screw.Revision surgery was performed on (b)(6) 2020.During the revision procedure, the 4 locking caps and rod on the left were removed and replaced with a new rod and 4 new locking caps.The locking caps on the right side were re-torqued to confirm they were appropriately locked.The wound was washed and then closed.Procedure was successfully completed.It is unknown if there was a surgical delay.There was patient consequence.Concomitant device reported: rod, str, ti, 450mm (hx end) (part # 179963450 , lot # unknown, quantity # 1).This report is for one (1) exp 635 ti si setscrew.This is report 1 of 3 for (b)(4).

• Brand Name: EXP 635 TI SI SETSCREW
• 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): BRIDGEWATER DISTRIBUTION; 50 scotland boulevard; bridgewater MA 02324
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 6103142063
• MDR Report Key: 9883882
• MDR Text Key: 193297856
• Report Number: 1526439-2020-00770
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034084664
• UDI-Public: (01)10705034084664
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160904
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/28/2020

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
• Device Operator: Health Professional
• Device Model Number: 179902000
• Device Catalogue Number: 179902000
• Device Lot Number: 258323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2020
• Initial Date FDA Received: 03/26/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Weight: 84