MAUDE Adverse Event Report: ALPHATEC SPINE, INC. ARCUS GUIDED ACCESS SYSTEM - BEVEL TIP, STERILE; NEUROSURGICAL NERVE LOCATOR

Model Number 16122-02-S

Device Problems Break (1069); Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/15/2021

Event Type  Injury  

Manufacturer Narrative

The device has not returned.If any additional information is provided, a supplemental report will be submitted.

Event Description

A targeting needle broke in the patient while being used by the surgeon.All pieces were recovered.No patient injury reported.

Manufacturer Narrative

The following information was provided by the sales representative regarding this investigation: the patient had extremely hard bone which required lots of extra malleating.When the surgeon was malleating, the distal tip of the sheath broke off and was easily retrieved.No patient injury reported.The device has not returned to atec.If any additional information is provided, a supplemental report will be submitted.

• Brand Name: ARCUS GUIDED ACCESS SYSTEM - BEVEL TIP, STERILE
• Type of Device: NEUROSURGICAL NERVE LOCATOR
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 1950 camino vida roble; carlsbad CA 92008
• MDR Report Key: 12360431
• MDR Text Key: 267895964
• Report Number: 2027467-2021-00059
• Device Sequence Number: 1
• Product Code: PDQ
• UDI-Device Identifier: 00190376240275
• UDI-Public: 00190376240275
• Combination Product (y/n): N
• PMA/PMN Number: K191723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/26/2021

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
• Device Operator: No Information
• Device Model Number: 16122-02-S
• Device Catalogue Number: 16122-02-S
• Device Lot Number: SH211243488
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/26/2021
• Initial Date FDA Received: 08/24/2021
• Supplement Dates Manufacturer Received: 07/26/2021
• Supplement Dates FDA Received: 09/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other