MAUDE Adverse Event Report: PRECISION SPINE, INC. MODULAR POLYAXIAL TULIP ASSEMBILES; PEDICLE SCREW SYSTEM

Catalog Number 39-MT-0301

Device Problems Fitting Problem (2183); Device-Device Incompatibility (2919)

Patient Problem No Code Available (3191)

Event Date 05/11/2018

Event Type  Injury  

Manufacturer Narrative

Patient information - no patient information was provided.Occupation - sales representative.Evaluation - product is expected to be returned for evaluation but has yet to be received.Should the product be received a supplemental report will be filed to relay the results of the evaluation.Review of device history records found 35 pieces of this lot were received released for distribution on (b)(6) 2014 with no deviation or anomalies.Two year complaint history review found this to be the first report of this nature for the reported part number.As no conclusions can be drawn without the opportunity to examine the product, no corrective actions were required.

Event Description

Precision reform modular screw were placed at l3, l4, l5, s1.When the surgeon tried to install the rod, the rod would not fit into the head.The surgeon had to remove the screws and utilize another company's product.There was a delay to the procedure of approximately 45 minutes as a result of this issue.

Manufacturer Narrative

Evaluation of returned product determined that the reported issue was not attributed to the lordotic rod.Returned rod was found to be within design specification.It was identified that the modular tulip component was labeled and distributed as part number 39-mt-0301 but the product was actually etched as 59-mt-0301.The design of the 59-mt-0301 is not compatible with the 39-lc-5080 lordotic rod that is part of the reform modular system being used in this procedure.The root cause is attributed to product mislabeling.A capa was initiated to address this issue.

• Brand Name: MODULAR POLYAXIAL TULIP ASSEMBILES
• Type of Device: PEDICLE SCREW SYSTEM
• Manufacturer (Section D): PRECISION SPINE, INC.; 2050 executive dr; pearl MS 39208
• MDR Report Key: 7789474
• MDR Text Key: 117321093
• Report Number: 3005739886-2018-00027
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• PMA/PMN Number: K121172
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 39-MT-0301
• Device Lot Number: 13049PS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention