MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MMSI SINGLE INNER SETSCREW; ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION

Catalog Number 179712000

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/11/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow up report will be submitted upon completion of the investigation.

Event Description

Sliding wires.During the lumbar surgery, sliding wires occurred before locking the screws and nuts.

Manufacturer Narrative

Product complaint # (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.

• Brand Name: MMSI SINGLE INNER SETSCREW
• Type of Device: ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT'L SARL; chemin-blanc 38; le locle ; SZ
• Manufacturer Contact: jason busch ; 325 paramount dr; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7683198
• MDR Text Key: 114047024
• Report Number: 1526439-2018-50667
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K030383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Caregivers
• Type of Report: Initial,Followup
• Report Date: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 179712000
• Device Lot Number: ATJB3B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1