MAUDE Adverse Event Report: STRYKER SPINE-US BLOCKER; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	48850000
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	08/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device remains implanted.
Event or Problem Description
A physician reported that a xia ct blocker migrated from s1 approximately eight months post-operatively.The physician plans to perform an alif at l5 to s1 but it is not known if they intend to revise the posterior construct during this surgery.
Additional Manufacturer Narrative
Device analysis could not be performed because the device remains implanted.The device lot number was not provided; therefore, product history and complaint history could not be performed.It was reported that the xia 4.5 torque wrench was used to tighten the blocker to 8 nm.There is no issue with the concomitantly placed devices.The patient did not experience a fall after initial surgery and the patient's postoperative activity level is unknown.From the xia 4.5 surgical technique: once the correction procedures have been carried out and the spine is fixed in a satisfactory position, the final tightening of the blockers is performed.To final tighten; use the anti-torque key and the torque wrench: step 1: place the anti-torque key over the screw head.Step 2: place the torque wrench through the anti-torque key until it is guided into the blocker.Step 3: line up the two arrows to achieve the final tightening torque of 8nm.The torque wrench indicates the optimal torque force that must be applied to the implant for final tightening.Note: do not exceed 8nm during final tightening.The anti-torque key must be used for final tightening.The anti-torque key performs two key functions: allows the torque wrench to align with the tightening axis; helps to maximize the torque needed to lock the implant assembly.From the xia ifu: while the expected life of spinal implant components is difficult to estimate, it is finite.These components are made of foreign materials which are placed within the body for the potential fusion of the spine and reduction of pain.However, due to the many biological, mechanical and physicochemical factors which affect these devices but cannot be evaluated in vivo, the components cannot be expected to indefinitely withstand the activity level and loads of normal healthy bone.The root cause of the reported event cannot be determined as the device was not returned for evaluation.Potential root causes: surgeon "white knuckles" the torque wrench; surgeon unable to read the laser marking; blocker cross threads with the screw; atk is not fully connected to the screw; torque wrench is not able to provide enough torque.
Event or Problem Description
A physician reported that a xia ct blocker migrated from s1 approximately eight months post- operatively.The physician plans to perform an alif at l5 to s1 but it is not known if they intend to revise the posterior construct during this surgery.

• Brand Name: BLOCKER
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 9131813
• Report Number: 0009617544-2019-00114
• Device Sequence Number: 19535960
• Product Code: NKB
• UDI-Device Identifier: 07613327132526
• UDI-Public: 07613327132526
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K152632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 48850000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/29/2019
• Supplement Date Received by Manufacturer: 10/03/2019
• Initial Report FDA Received Date: 09/27/2019
• Supplement Report FDA Received Date: 11/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention