MAUDE Adverse Event Report: BIEDERMANN MOTECH GMBH & CO. KG MOSS VRS; PEDICLE SCREW SYSTEM

Model Number UNKNOWN

Device Problem Patient Device Interaction Problem (4001)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/01/2019

Event Type  Injury  

Manufacturer Narrative

Ethnicity: ethnicity and race are unknown.Udi #: udi information is not available.The device was not returned and the lot is unknown.There were no complication reported during revision and this complaint or a similar complaint has not been reported to the importer before.As confirmed by the manufacturer, no further action is required.If additional information becomes available, a follow-up medwatch report will be submitted.

Event Description

This is an importer report for an event reported by the manufacturer.Reference manufacturer report # 8010944-2019-00001.Posterior spinal stabilization surgery from t10 to s2 with pedicle subtraction osteotomy at l4 was performed.2 straight rods were bent approx.50 degrees before implantation to achieve the correction.There were no complications reported during the surgery.During the follow-up examination it was discovered that both rods had bent back by approx.30 degrees, had moved upwards and that the achieved correction was reduced.A revision surgery was performed in which a 4 rod construct and an anterior support cage were used.There were no complications reported during the revision surgery.

• Brand Name: MOSS VRS
• Type of Device: PEDICLE SCREW SYSTEM
• Manufacturer (Section D): BIEDERMANN MOTECH GMBH & CO. KG; bertha-von-suttner strasse 3; villingen-schwenningen, 78054 ; GM 78054
• MDR Report Key: 8745445
• MDR Text Key: 149551450
• Report Number: 3013248720-2019-00002
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/28/2019
• Distributor Facility Aware Date: 06/12/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 120