MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL EXP TI POLY SCREW 8MMX80MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	179712880
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Not Applicable (3189)
Date of Event	03/02/2018
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
Iliac screw was being inserted under the expedium power set.The expedium power driver shaft broke in the process, along with the head of the iliac screw.Patient consequence? :no action taken for procedure:screw was removed and we grabbed our backup expedium driver to continue the procedure.Is the information being submitted for this complaint all the details that are known/available regarding this event? : yes.

• Brand Name: EXP TI POLY SCREW 8MMX80MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle ; SZ
• MDR Report Key: 7382111
• Report Number: 1526439-2018-50276
• Device Sequence Number: 10795279
• Product Code: NKB
• UDI-Device Identifier: 10705034068145
• UDI-Public: (01)10705034068145
• Combination Product (Y/N): N
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 179712880
• Device Catalogue Number: 179712880
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/04/2018
• Initial Report FDA Received Date: 03/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 104