MAUDE Adverse Event Report: STRYKER SPINE-FRANCE FIXED ANGLE BONE SCREW SELF-DRILLING DIAM 4.0 X 12MM; IMPLANT-SCREW

Catalog Number 48654012

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 09/03/2014

Event Type  Injury  

Event Description

It was reported the surgeon did a 4 level acdf using our dynatran plate with reflex hybrid fixed self-drilling screws with a 76mm plate.A combination of 12mm and 14mm screws were used with the plate with no apparent issues or difficulty.Later in the evening, however, the patient was brought back to surgery due to a bleeding issue at c6-7.No stryker rep was in attendance, just the surgeon and his assistant.The decision was made to remove and adjust the 4 level plate, in the process 6 of the screws were removed using the revision screwdriver and stylus.At some point the threaded tip of the stylus had broken off and the remaining 4 screws were not able to be removed from the plate.The plate was finally removed with some difficulty.At this point the surgeon took a new 76mm plate with 10 new screws (14mm, 16mm, 18mm) and finished the case.

Manufacturer Narrative

Fixed angle bone screw self-drilling diam 4.0 x 12mm.Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment; results: the screws were visually examined and no anomalies were found.Manufacturing files were reviewed and no issues were found for this lot number.Conclusion: it was not known what caused the bleeding (surgical procedure, patient anatomy or implants) so the root cause is not determined.

Event Description

It was reported the surgeon did a 4 level acdf using our dynatran plate with reflex hybrid fixed self-drilling screws with a 76mm plate.A combination of 12mm and 14mm screws were used with the plate with no apparent issues or difficulty.Later in the evening, however, the patient was brought back to surgery due to a bleeding issue at c6-7.No stryker rep was in attendance, just the surgeon and his assistant.The decision was made to remove and adjust the 4 level plate, in the process 6 of the screws were removed using the revision screwdriver and stylus.At some point the threaded tip of the stylus had broken off and the remaining 4 screws were not able to be removed from the plate.The plate was finally removed with some difficulty.At this point the surgeon took a new 76mm plate with 10 new screws (14mm, 16mm, 18mm) and finished the case.

• Brand Name: FIXED ANGLE BONE SCREW SELF-DRILLING DIAM 4.0 X 12MM
• Type of Device: IMPLANT-SCREW
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 3361 0; FR 33610
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 3361 0; FR 33610
• Manufacturer Contact: linford leitch ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 4129372
• MDR Text Key: 4798101
• Report Number: 0009617544-2014-00421
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 48654012
• Device Lot Number: EUE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/04/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/18/2014
• 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): Required Intervention
• Patient Age: 49 YR