MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN SCREWS; SCREW,FIXATION,BONE

Model Number	199723645
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional device product code: mni.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative 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 initially on (b)(6) 2019 the patient underwent a l3/5 posterolateral interbody fusion procedure.Patient was recently seen by surgeon for back pain.Postoperatively a broken screw was identified in the construct.The broken screw is still in situ as there has been no plan for revision surgery at this point in time.Surgeon mentioned that back pain may not be directly related to the broken screw.No further information is available.Concomitant device reported: concorde bul par 9x11x23 (part# 187823111, lot# unknown, quantity 4); 5.5 exp verse unitized set scr (part# 199721001, lot# unknown, quantity 5); 5.5 exp verse fen scr 6.0x45 (part# 199723645, lot# unknown, quantity 3); 5.5 exp verse fen scr 6.0x40 (part# 199723640, lot# unknown, quantity 1); mmsi rod prebent, 5.5 x65mm, t (part# 179772065, lot# unknown, quantity 2).This report is for one (1) 5.5 exp verse fen scr 6.0x45.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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
Concomitant device reported: unknown screw (part# unknown, lot# unknown, quantity 1).
Event or Problem Description
Device report from synthes reports an event in australia as follows: it was reported that initially on (b)(6) 2019 the patient underwent a l3/5 posterolateral interbody fusion procedure.Patient was recently seen by surgeon for back pain.Postoperatively a broken screw was identified in the construct.The broken screw is still in situ as there has been no plan for revision surgery at this point in time.Surgeon mentioned that back pain may not be directly related to the broken screw.No further information is available.Concomitant device reported: concorde bul par 9x11x23 (part# 187823111, lot# unknown, quantity 4); 5.5 exp verse unitized set scr (part# 199721001, lot# unknown, quantity 5); 5.5 exp verse fen scr 6.0x45 (part# 199723645, lot# unknown, quantity 3); 5.5 exp verse fen scr 6.0x40 (part# 199723640, lot# unknown, quantity 1); mmsi rod prebent, 5.5 x65mm, t (part# 179772065, lot# unknown, quantity 2).This report is for one (1) unknown screws.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.D1, d2, d3, d4, g5 ¿ 510k: this report is for an unknown screws/unknown lot.Part and lot numbers are unknown; udi number is unknown.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.

• Brand Name: UNKNOWN SCREWS
• Common Device Name: SCREW,FIXATION,BONE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10089354
• Report Number: 1526439-2020-01081
• Device Sequence Number: 14109806
• Product Code: HWC
• UDI-Device Identifier: 10705034403083
• UDI-Public: (01)10705034403083
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K160879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/11/2020

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: 199723645
• Device Catalogue Number: 199723645
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/11/2020
• Supplement Date Received by Manufacturer: 05/25/2020; 05/29/2020
• Initial Report FDA Received Date: 05/26/2020
• Supplement Report FDA Received Date: 05/28/2020; 06/05/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5.5 EXP VERSE FEN SCR 6.0X40; 5.5 EXP VERSE FEN SCR 6.0X45; 5.5 EXP VERSE UNITIZED SET SCR; CONCORDE BUL PAR 9X11X23; MMSI ROD PREBENT, 5.5 X65MM, T; UNKNOWN SCREWS
• Outcome Attributed to Adverse Event: Required Intervention