MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SINGLE INNER POLYAXIAL SCREW 5.5 X 7.00 X 50MM; EXPEDIUM SPINE SYSTEM

Model Number	179712750
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without a lot number the device history records review could not be completed.Product was not returned.(b)(4).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 on (b)(6) 2019, the patient underwent surgery for the extension of the spondylodesis to l3 because of adjacent segment degeneration and stenosis.Previous surgery for spondylodesis/fusion l4-s1 was done on 2015.The procedure and patient outcome is unknown.This complaint involves unknown number of devices.This complaint is for one (1) single inner polyaxial screw 5.5 x 7.00 x 50mm.This report is 4 of 4 for (b)(4).

• Brand Name: SINGLE INNER POLYAXIAL SCREW 5.5 X 7.00 X 50MM
• Common Device Name: EXPEDIUM SPINE SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9444132
• Report Number: 1526439-2019-52647
• Device Sequence Number: 16745027
• Product Code: NKB
• UDI-Device Identifier: 10705034067919
• UDI-Public: (01)10705034067919
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/13/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: 179712750
• Device Catalogue Number: 179712750
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 12/10/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Weight: 85