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

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Spinal Column Injury (2081)

Event Date 07/04/2018

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

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
• 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
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7762323
• MDR Text Key: 116412632
• Report Number: 1526439-2018-50756
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034064888
• UDI-Public: (01)10705034064888
• Combination Product (y/n): N
• PMA/PMN Number: K160904
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 179702645
• Device Catalogue Number: 179702645
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention