MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND 7.5X45 POLYAXIAL SCREW; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Model Number	482617545
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Foreign Body In Patient (2687)
Date of Event	11/06/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; 7.5x45 screws (two of them at l4 and l5) fractured the pedicles.Screws remained in the patient and case was completed.
Additional Manufacturer Narrative
Method: risk assessment;   result:the customer reported event was confirmed via correspondence with the sales representative.The screw is still implanted and the lot number is unknown.Thus, product inspection and device history review could not be completed.For the reported screws, tapping is recommended in most cases.Undertapping may cause the screw to become bound in the bone, and with the excess torque applied to drive the screw down, may cause the pedicle to fracture.It was confirmed that for this case, the screw hole was undertapped with a 6.5mm tap for a 7.5mm screw.The most likely root cause is undertapping of the screw hole, causing excess torque that fractured the pedicle.
Event or Problem Description
It was reported that; 7.5x45 screws (two of them at l4 and l5) fractured the pedicles.Screws remained in the patient and case was completed.

• Brand Name: 7.5X45 POLYAXIAL SCREW
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• MDR Report Key: 7052219
• Report Number: 3005525032-2017-00107
• Device Sequence Number: 11049206
• Product Code: KWP
• UDI-Device Identifier: 07613327351408
• UDI-Public: (01)07613327351408
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2018

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: No Information
• Device Model Number: 482617545
• Device Catalogue Number: 482617545
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/06/2017
• Supplement Date Received by Manufacturer: 01/29/2018
• Initial Report FDA Received Date: 11/22/2017
• Supplement Report FDA Received Date: 02/24/2018
• 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: Other
• Patient Age: 78 YR
• Patient Weight: 77