MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXPEDIUM SPINE SYSTEM SIDE LOADING OPEN/OPEN TOP NOTCH CONNECTOR 6.35 X 5.5MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number 179771555

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/10/2020

Event Type  Injury  

Manufacturer Narrative

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.(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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, the universal connector set was received with the incorrect implants contained in the set.Instead of four, there were only two contained in the set.The surgeon had to use a competitor product to ensure that the procedure was completed.There was a surgical delay of two minutes.The procedure was successfully competed.This report is for one (1) expedium spine system side loading open/open top notch connector 5.5 x 5.5mm.This is report 1 of 2 for (b)(4).

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d4: lot and expiration date.A review of the receiving inspection (ri) for conn o/o sd top ntch 5.5x6.35 was conducted identifying that lot number nw250651 was released in a single batch.Batch1: lot qty of (b)(4) units were released on march 23, 2020 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.The ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Investigation flow: visual.Visual inspection: the conn o/o sd top ntch 5.5 x6.35 (p/n: 179971555, lot #: nw250651) was returned and received at us customer quality (cq).Upon visual inspection, no issues were identified with the returned device.The stocking device not available/missing condition cannot be confirmed with the provided information.Device failure/defect identified? no.Document/specification review based on the date of manufacture, the current and manufactured revision of drawings were reviewed -expedium adult: 6.35 embedded top notch connector, ti.Complaint confirmed? no.Investigation conclusion.The complaint condition was not confirmed for the conn o/o sd top ntch 5.5 x6.35 (p/n: 179971555, lot #: nw250651).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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.D4: unique identifier( udi) and catalog.G1: manufacturing site name.

• Brand Name: EXPEDIUM SPINE SYSTEM SIDE LOADING OPEN/OPEN TOP NOTCH CONNECTOR 6.35 X 5.5MM
• Type of Device: 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: 10960186
• MDR Text Key: 219976389
• Report Number: 1526439-2020-02364
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034077819
• UDI-Public: (01)10705034077819
• Combination Product (y/n): N
• PMA/PMN Number: K160904
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/10/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: 179771555
• Device Catalogue Number: 179971555
• Device Lot Number: NW250651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2021
• Initial Date Manufacturer Received: 11/10/2020
• Initial Date FDA Received: 12/07/2020
• Supplement Dates Manufacturer Received: 12/09/2020; 01/07/2021
• Supplement Dates FDA Received: 01/05/2021; 01/20/2021
• Patient Sequence Number: 1
• Treatment: CONN O/O SD TOP NTCH 5.5X5.5 T; CONN O/O SD TOP NTCH 5.5X5.5 T
• Patient Outcome(s): Required Intervention