MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE FEN SCR 7.0X45; BONE-SCREW INTERNAL SPINAL FIXATION SYSTEM, NON-STERILE

Model Number	199723745
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review/ investigation.Without a lot number, the device history records review could not be completed as no product was received.Investigation summary: e action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.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
Device report from synthes reports an event in (b)(6) as follows: it was reported that a pedicle fracture breakage.The surgeon inserted the screws without i/i controlled.Screws were all in place, when the surgeon was about to use the sri verse distractor, he connected the sri distraction sleeve apau0231, locked them which may have generated the breakage.Concomitant device reported: unknown ri verse distractor (part # unknown, lot # unknown , quantity 1), unknown sri distraction sleeve (part # apau0231, lot # unknown, quantity 1).This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

• Brand Name: 5.5 EXP VERSE FEN SCR 7.0X45
• Common Device Name: BONE-SCREW INTERNAL SPINAL FIXATION SYSTEM, NON-STERILE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10123945
• Report Number: 1526439-2020-01117
• Device Sequence Number: 2850641
• Product Code: PML
• UDI-Device Identifier: 10705034402918
• UDI-Public: (01)10705034402918
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K160879
• 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): 05/26/2020

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: 199723745
• Device Catalogue Number: 199723745
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/26/2020
• Initial Report FDA Received Date: 06/05/2020
• Patient Sequence Number: 1
• Patient Age: 71 YR