MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA DEFORMITY REDUCTION LONG ARM POLYAXIAL SCREW 6.5 X 45MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number 03829645

Device Problems Break (1069); Mechanical Problem (1384); Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/03/2015

Event Type  malfunction  

Event Description

It was reported that; when doctor used the spreader to distract the screws, he found the reduction polyaxial screw's head fixed and cannot move any more.The same accidents happened in other 2 normal polyaxial screws.Doctor changed all the 3 bad screws.After operation,the reduction screw's head became normally movable by heavy force from dealer, and the rest 2 screws are still fixed.And one lumber's pedicles were broken because of the heavy force of the distraction of fixed polyaxial screws, doctor decide to not insert screws any more in this lumber.

Manufacturer Narrative

Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment; results: no relevant issues were identified in the manufacturing records.All units were inspected and met stryker specifications.The reported event couldn't be confirmed, the device was found upon visual and functional inspection to fully operational.Conclusion: the plausible root cause is user failed to adhere to operating instructions.No other anomalies were observed.

Event Description

It was reported that; when doctor used the spreader to distract the screws ,he found the reduction polyaxial screw's head fixed and cannot move any more.The same accidents happened in other 2 normal polyaxial screws.Doctor changed all the 3 bad screws.After operation,the reduction screw's head became normally movable by heavy force from dealer, and the rest 2 screws are still fixed.And one lumber铠pedicles were broken because of the heavy force of the distraction of fixed polyaxial screws, doctor decide to not insert screws any more in this lumber.

• Brand Name: XIA DEFORMITY REDUCTION LONG ARM POLYAXIAL SCREW 6.5 X 45MM
• Type of Device: PEDICLE SCREW SPINAL SYSTEM
• 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: 4999501
• MDR Text Key: 24145491
• Report Number: 0009617544-2015-00360
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K061854
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 07/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 03829645
• Device Lot Number: 13E552
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/16/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/27/2013
• 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