MAUDE Adverse Event Report: ALPHATEC SPINE INC POLYAXIAL SCREW REMOVER (STAINLESS STEEL); HXX

Model Number	62941
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No evaluation possible at this time.Multiple attempts to obtain the instrument in question have been unsuccessful.Upon the receipt of additional information and/or the return of the device, a follow-up report will be submitted.The detached section which remains entrapped within the implanted polyaxial screw, is approximately.185" in length and is manufactured from 17-4 (stainless steel).The raw material is processed and certified according to astm a564 standards.
Event or Problem Description
The distal tip of a polyaxial screw remover broke off during an explant.The detached tip remains positioned within the head of the polyaxial screw, implanted within the patient.

• Brand Name: POLYAXIAL SCREW REMOVER (STAINLESS STEEL)
• Common Device Name: HXX
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 8678560
• Report Number: 2027467-2019-00030
• Device Sequence Number: 2003968
• Product Code: HXX
• UDI-Device Identifier: 00844856006102
• UDI-Public: (01)00844856006102(10)7588602
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/10/2019

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: Health Professional
• Device Model Number: 62941
• Device Catalogue Number: 62941
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/10/2019
• Initial Report FDA Received Date: 06/07/2019
• 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