MAUDE Adverse Event Report: SYNTHES GMBH 5.0MM TI CANNULATED MATRIX SCREW 45MM THREAD LENGTH; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number 04.616.545S

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional product code: mnh, mni, kwq, kwp.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.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing 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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent for a revision surgery due to the screw at l5 left had backed out.On (b)(6) 2021, the patient had a tlif treating lumbar spinal canal stenosis.It was unknown if the revision surgery completed successfully.The patient outcome was unknown.Concomitant device reported: unk - rods: lumbar spine (part # unknown; lot # unknown; quantity: 1), unk - locking/set screws: matrix (part # unknown; lot # unknown; quantity: unknown).This complaint involves one(1) device.This report is for (1) 5.0mm ti cannulated matrix screw 45mm thread length.This report is 1 of 1 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: h6: health effect clinician code 2402 used to capture injury.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: 5.0MM TI CANNULATED MATRIX SCREW 45MM THREAD LENGTH
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12321104
• MDR Text Key: 266603934
• Report Number: 8030965-2021-06684
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07611819366534
• UDI-Public: (01)07611819366534
• Combination Product (y/n): N
• PMA/PMN Number: K100952
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.616.545S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/12/2021
• Patient Sequence Number: 1
• Treatment: UNK - LOCKING/SET SCREWS: MATRIX.; UNK - RODS: LUMBAR SPINE.
• Patient Outcome(s): Required Intervention