MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXP DI POLYAXL SCRW 7 X 45MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	179722745
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that on (b)(6) 2019, the patient underwent a removal procedure due to a broken left l5 pedicle/poly screw underneath the tulip.Originally, the patient underwent l3-l5 posterior instrumented fusion on (b)(6) 2011.However, on an unknown date, the screw was noted to be broken.Thus, a hardware removal was performed where all set screws, rod and pedicle screws were removed and was not replaced.No fragments were generated from broken device.However, screws were removed with little difficulty.The procedure was successfully completed with no surgical delay.Patient outcome was unknown.Original event description: dr (b)(6), (b)(6) hospital, (b)(6) 2019.The patient had a broken left l5 pedicle screw, the screw broke underneath the tulip.The previous operation was l3-l5 posterior instrumented fusion on (b)(6) 2011 at (b)(6) hospital.Dr removed all set screws, rods and pedicle screws.No screws were replaced or available for return.Unknown when screw broke.Patient initials: (b)(6).

• Brand Name: EXP DI POLYAXL SCRW 7 X 45MM
• 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: 8556697
• Report Number: 1526439-2019-51570
• Device Sequence Number: 3236601
• Product Code: NKB
• UDI-Device Identifier: 10705034070803
• UDI-Public: (01)10705034070803
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/01/2019

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: 179722745
• Device Catalogue Number: 179722745
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2019
• Initial Report FDA Received Date: 04/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention