MAUDE Adverse Event Report: SPINE WAVE, INC. SPINE WAVE PEDICLE SCREW PA SKIPER, ROD LORD, LOCKING SCREW; ORTHOSIS, SPINAL PEDICLE FIXATION

Model Number 11-4645, 11-4080, 11-4001

Device Problems Break (1069); Entrapment of Device (1212); Loose or Intermittent Connection (1371)

Patient Problems Pain (1994); Device Embedded In Tissue or Plaque (3165)

Event Date 04/28/2021

Event Type  Injury  

Event Description

In 2020, patient sustained a fracture of the l2 vertebral with retropulsion of the vertebral body into the spinal canal requiring a l1-l3 pedicle screw fixation with decompression.Spine wave locking screw, rod, and pedicle screw were implanted during surgery.In 2021, patient was doing somewhat heavy lifting at work and felt pain in his back.Imaging revealed loosening involving the pedicle screw fragments within the pedicles.Patient underwent surgery to remove instrumentation, pedicle screws noted to be broken and unable to be removed during surgery.Patient has residual screw fragments in the l1 vertebral body.Fda safety report id # (b)(4).

• Brand Name: SPINE WAVE PEDICLE SCREW PA SKIPER, ROD LORD, LOCKING SCREW
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): SPINE WAVE, INC.
• MDR Report Key: 12294062
• MDR Text Key: 265977501
• Report Number: MW5103083
• Device Sequence Number: 1
• Product Code: MNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/04/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11-4645, 11-4080, 11-4001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 18 YR
• Patient Weight: 61