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

Model Number	179702645
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	07/04/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Procedure/surgery name: ais scoliosis correction / spine.Procedure/surgery date : (b)(6) 2018.Describe event: post operative, the most caudal setscrew on the left side came loose out of the monoaxial screw.Due to this, the rod was loosed out of the caudal part of the construct.Surgeon removed total construct in a revision surgery what action was taken/required to manage the problem during the procedure ? primary surgery was on (b)(6) 2013.Post op problem occurred and on (b)(6) 2018 the revision surgery took place.How long was the procedure prolonged as a result of the difficulties encountered with the device(minutes)? no delay.Problem occured post op.

• Brand Name: MONOAXIAL SCREW 6 X 45MM
• Common Device Name: 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: 7762323
• Report Number: 1526439-2018-50756
• Device Sequence Number: 1757701
• Product Code: NKB
• UDI-Device Identifier: 10705034064888
• UDI-Public: (01)10705034064888
• Combination Product (Y/N): N
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/13/2018

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: 179702645
• Device Catalogue Number: 179702645
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2018
• Initial Report FDA Received Date: 08/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention