MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE CAN SCR 8.0X75; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number 199725875S

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown screws/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021 it was found that one of the tabs of the screw had not been cut off during the final fixation.On (b)(6) 2021 the patient underwent a spinal fusion and correction procedure at t4-sai treating scoliosis.The patient has not suffered from pain but is scheduled to undergo a revision procedure on (b)(6).No further information is available.This complaint involves one (1) device.This report is for (1) unknown screws.This is report 1 of 1 (b)(4).

Event Description

Device report from synthes reports an event in japan as follows: it was reported that on (b)(6) 2021 it was found that one of the tabs of the screw had not been cut off during the final fixation.On (b)(6) 2021 the patient underwent a spinal fusion and correction procedure at t4-sai treating scoliosis.The patient has not suffered from pain but is scheduled to undergo a revision procedure on (b)(6).No further information is available.It took ten minutes to complete the revision without further issue on (b)(6) 2021.The alleged screw remains in the patient's body.

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: d2: additional pro-code: kwp;kwq;mnh;mni;osh investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and 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.

• Brand Name: 5.5 EXP VERSE CAN SCR 8.0X75
• 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
• MDR Report Key: 11340438
• MDR Text Key: 232334612
• Report Number: 1526439-2021-00311
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K142185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 199725875S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/18/2021
• Patient Sequence Number: 1
• Treatment: UNKNOWN SCREWS
• Patient Outcome(s): Required Intervention
• Patient Age: 17 YR