MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA RAD ROD L45; PEDICLE SCREW SPINAL SYSTEM

Catalog Number 48218045

Device Problems Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Reaction (2414)

Event Date 05/20/2016

Event Type  Injury  

Event Description

It was reported that; patient received a posterior lumbar decompression infusion at l4-l5 in (b)(6) 2014.She recently started to experience a lot of aching and pain and her surgeon suggests this may be an allergic reaction to the implant.

Manufacturer Narrative

Risk assesment; device history review could not be performed as no lot code was provided.Device evaluation could not be performed as no items were returned.Complaint history review could not be performed as no lot code was provided.The event could not be confirmed nor the root cause determined because the devices were not returned for evaluation and/or insufficient information was provided for review.Per the ifu; "when hypersensitivity is suspected or proven, it is recommended that the tolerance of the skin to the materials that make up the implants be checked before they are implanted" and "pain, discomfort, or abnormal sensations due to the presence of the device" are known adverse effects and removal may also be recommended in "pain or abnormal sensations due to the presence of the implants.Infection or inflammatory reactions".The exact root cause could not be determined because the devices were not returned for evaluation and/or insufficient information was provided for review.

Event Description

It was reported that; patient received a posterior lumbar decompression infusion at l4-l5 in (b)(6) 2014.She recently started to experience a lot of aching and pain and her surgeon suggests this may be an allergic reaction to the implant.

• Brand Name: XIA RAD ROD L45
• Type of Device: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• Manufacturer (Section G): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• Manufacturer Contact: rakshya bista ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 5920657
• MDR Text Key: 53682142
• Report Number: 3005525032-2016-00098
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 04546540433879
• UDI-Public: (01)04546540433879
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 48218045
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Other
• Patient Age: 63 YR