MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SI POLYAXL SCREW 7 X 35MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	179712735
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional device product codes: kwp; kwq; mnh; mni; osh.Complainant part is expected to be returned for manufacturer review/ investigation, but has yet to be received.Occupation: reporter is company employee.(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 the patient underwent original l5/s1 fusion surgery on (b)(6) 2017.On an unknown postoperative date s1 screws fractured and l5 screws loosened, which resulted in need for revision procedure on (b)(6) 2019 to remove broken screws and revise both l5 and s1 screws due to pain and dysfunction.This was a planned revision surgery.There was surgical delay of approximately fifteen (15) minutes to remove broken screws.No further information provided.Concomitant device reported: unknown rod (part # unknown, lot # unknown, quantity 1).This is report 1 of 6 for complaint (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).Udi: (b)(4).Product was not returned.Based on the information available, it has been determined that no corrective and 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.

• Brand Name: SI POLYAXL SCREW 7 X 35MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9371245
• Report Number: 1526439-2019-52487
• Device Sequence Number: 14169770
• Product Code: NKB
• UDI-Device Identifier: 10705034067889
• UDI-Public: (01)10705034067889
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2019

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: 179712735
• Device Catalogue Number: 179712735
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/30/2019
• Supplement Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 01/22/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN RODS
• Outcome Attributed to Adverse Event: Required Intervention