MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI POLYAXIAL HEAD FOR USS POLYAXIAL; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number 04.607.402

Device Problem Compatibility Problem (2960)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/16/2021

Event Type  malfunction  

Manufacturer Narrative

Additional procode: mni, mnh, kwp, kwq.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.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 during a pediatric deformity case, two (2) ti polyaxial heads popped off the scres before the rod was inserted into the construct.The procedure was completed using a new polyaxial head.There was no surgical delay reported.There is no further information available.This report is for one (1) ti polyaxial head for uss polyaxial.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.H3, h4, h6: device history lot: product code: 04.607.402.Lot number: 66p5279.Manufacturing site: mezzovico.Release to warehouse date: 11 aug 2020.A manufacturing record evaluation was performed for the not sterile device lot number, and no non-conformances were identified.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: TI POLYAXIAL HEAD FOR USS POLYAXIAL
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11489990
• MDR Text Key: 243937982
• Report Number: 2939274-2021-01317
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07611819186361
• UDI-Public: (01)07611819186361
• Combination Product (y/n): N
• PMA/PMN Number: K082572
• 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: 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.607.402
• Device Lot Number: 66P5279
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/16/2021
• Patient Sequence Number: 1
• Treatment: USS-II POLYAXIAL 3D-HEAD F/R Ø6 TAN GREE