MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXP TI UNI SCREW 6MM X 45MM; ORTHOSIS, SPINAL PEDICLE FIXATION

Catalog Number	179788645
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	07/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Upon visual inspection of the returned device, it was observed that the thread was torn.Rest of the device showed no signs of damage.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 and hence the root cause cannot be determined.But the potential cause could be due to unintended forces.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.
Event or Problem Description
Revision fusion: (b)(6) hospital, (b)(6) 2019.Primary implant date: (b)(6) 2018.Thread was damaged when reducing rod to screw head using flex clip reducer.Replaced the screw with a polyaxial screw.No ae reported.5-10 minutes delay in the surgery.

• Brand Name: EXP TI UNI SCREW 6MM X 45MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9209100
• Report Number: 1526439-2019-52257
• Device Sequence Number: 16881770
• Product Code: MNI
• UDI-Device Identifier: 10705034081403
• UDI-Public: 10705034081403
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K160904
• 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
• Report Date (Section B): 07/30/2019

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 Catalogue Number: 179788645
• Device Lot Number: RL263377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2019
• Initial Report FDA Received Date: 10/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1