MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SI POLYAXL SCREW 6 X 45MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number 179712645

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This is a report of a revision case.The initial surgery on the patient was done in (b)(6) 2019.The elongation of the construct was needed due to loosening of the screws implanted in th10 vertebrae.Both of the screws were explanted and the construct was elongated to th7.The patient has parkinsons disease.Procedure/surgery name: posterior lumbar spinal construct elongation.Concomitant device reported: unknown rod (part# unknown, lot#unknown, quantity 1).This complaint involves two (2) devices.

Manufacturer Narrative

Product complaint # (b)(4).

• Brand Name: SI POLYAXL SCREW 6 X 45MM
• 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
• MDR Report Key: 9217701
• MDR Text Key: 176346517
• Report Number: 1526439-2019-52267
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034067735
• UDI-Public: (01)10705034067735
• Combination Product (y/n): N
• PMA/PMN Number: K160904
• 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: 09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 179712645
• Device Catalogue Number: 179712645
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention