MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE SCREW 7.0 X 50; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	199721750
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Spinal Column Injury (2081); Not Applicable (3189)
Date of Event	08/06/2018
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 the patient had a l2-s1 posterior spinal fusion in (b)(6) 2018 with depuy synthes spine "verse".The patient was found to have hardware related issues discovered on patient followup.The right l2 screw on xray appears to have cut through the pedicle cranially, and the initialed set screw was free floating.On (b)(6) dr.(b)(6) performed the revision.She removed all the set screws.As mentioned, the right l2 set screw was free floating.She commented that the bilateral l3 sets screws and left l2 set screw were very loose.She removed the rods.Dr.(b)(6) also found that the right s1 screw had broken right below the screw head (verse 7.0 x 50mm screw).She was able to get the screw shaft out and replaced the screw with an expedium poly screw.She also replaced the l2 screws (unknown size) and also extended the construct cranial to l1 and caudal to the ilium.The rod part # removed is unknown.Dr.(b)(6) then contoured rods and connected them.She successfully completed the procedure.Weight and height are unknown.No other information is available.No customer response needed.Patient consequence? no.Is the information being submitted for this complaint all the details that are known/available regarding this event? yes.

• Brand Name: 5.5 EXP VERSE SCREW 7.0 X 50
• 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: 7842822
• Report Number: 1526439-2018-50825
• Device Sequence Number: 16629373
• Product Code: NKB
• UDI-Device Identifier: 10705034442099
• UDI-Public: (01)10705034442099
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K142185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/06/2018

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: 199721750
• Device Catalogue Number: 199721750
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2018
• Initial Report FDA Received Date: 09/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR