MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC PIVOX OBLIQUE LATERAL SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number 2161001

Device Problem Break (1069)

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

Event Date 08/01/2018

Event Type  malfunction  

Manufacturer Narrative

Product analysis: visual review confirms the instrument's threaded tip has been completely broken off except for about 3 partial rows of threading left.No signs of thread damage.Optical examination of the fracture surface revealed a fairly brittle fracture surface.Conclusion: the above observations are consistent with bend stress overload.If information is provided in the future, a supplemental report will be issued.

Event Description

Pre-operative diagnosis: degenerative disc degeneration (ddd).Procedure: oblique lumbar interbody fusion (olif).Levels implanted: l3-l4-l5.It was reported that intra-op, the pivox tip of the inserter was broke while cage insertion.The broken fragments were retrieved by surgeon.The device came in contact with the patient.No patient complications occurred due to this event.

• Brand Name: PIVOX OBLIQUE LATERAL SPINAL SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 8066901
• MDR Text Key: 128046239
• Report Number: 1030489-2018-01479
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00643169639607
• UDI-Public: 00643169639607
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K152277
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2161001
• Device Lot Number: NM17A063
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/22/2018
• Date Device Manufactured: 05/11/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 65