MAUDE Adverse Event Report: STRYKER SPINE-FRANCE TRIO LX SMALL CONNECTOR; SPINAL INTERLAMINAL FIXATION ORTHOSIS.

Catalog Number 48902015

Device Problems Disconnection (1171); Fracture (1260); Mechanical Problem (1384); Mechanical Jam (2983)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)

Event Date 04/27/2017

Event Type  malfunction  

Event Description

It was reported that the device was implanted on (b)(6) 2016 for th12 of bone fracture.On (b)(6) 2017 it was removed as plan.But it couldn't loose the connector of th11 by the driver.So it was remained connector and rod on right side only.

Manufacturer Narrative

Method: device history review; complaint history review; risk assessment.Results: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Visual, dimensional and functional analysis could not be performed as the device was not returned.Conclusion: because the related connector was implanted in the body for some time.It is likely that the jamming is due to these causes.

Event Description

It was reported that the device was implanted on (b)(6) 2016 for th12 of bone fracture.(b)(6) 2017, it was removed the as plan.But it couldn't loose the connector of th11 by the driver.So it was remained connector and rod on right side only.

• Brand Name: TRIO LX SMALL CONNECTOR
• Type of Device: SPINAL INTERLAMINAL FIXATION ORTHOSIS.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: christa marrow ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 6583346
• MDR Text Key: 75839153
• Report Number: 0009617544-2017-00212
• Device Sequence Number: 1
• Product Code: KWP
• UDI-Device Identifier: 4546540494160
• UDI-Public: (01)4546540494160
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 48902015
• Device Lot Number: 158024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Weight: 52