MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE SCREW 7.0 X 45; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	199721745
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation 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
It was reported that on (b)(6) 2019, during insertion of the innie, the innie did not align properly and positioned itself into a displaced part of screws´s thread.There was no surgical delay and there was no patient consequence.This complaint involves four (4) devices.
Additional Manufacturer Narrative
Product complaint # = > (b)(4)., h4.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).Udi: (b)(4).Visual examination of the returned device found the extended tabs with loading zone were returned separately from the device.Upon visual inspection, it was observed that the drive feature between the hypermobile head and the threaded dual lead shank was jammed and seized.The internal threads of the head were observed to be stripped.No other issues were identified with the returned components of the device.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.There was no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer, this complaint file will be closed with no further action required.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 SCREW 7.0 X 45
• 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: 8803895
• Report Number: 1526439-2019-51843
• Device Sequence Number: 457642
• Product Code: NKB
• UDI-Device Identifier: 10705034442105
• UDI-Public: (01)10705034442105
• Combination Product (Y/N): N
• PMA/510(K) Number: K142185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/26/2019

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: 199721745
• Device Catalogue Number: 199721745
• Device Lot Number: 216837
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2019
• Initial Date Received by Manufacturer: 06/26/2019
• Supplement Date Received by Manufacturer: 08/22/2019; 09/18/2019
• Initial Report FDA Received Date: 07/18/2019
• Supplement Report FDA Received Date: 09/16/2019; 09/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1