MAUDE Adverse Event Report: ALPHATEC SPINE, INC. SAFEOP; IKD

Model Number	AIX1310-S
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned for evaluation.The root cause is unable to be determined at this time.If any additional information is provided, a supplemental report will be submitted.
Event or Problem Description
There was an issue encountered while performing ptp with a doctor.
Additional Manufacturer Narrative
B5: the clip was not picking up any readings with the initial dilator or any of the other two dilators.The needles were changed, replaced anterior tibial needle with a sticky pad, tried different clips, different dilators, a different safeop unit all together, nothing seemed to work until a fourth clip was tried with a different lot number.There was no report of patient injury.H6: medical device problem code: 2896 (communication or transmission problem).Component code: 758 (clip).Type of investigation: 4114 (device not returned); 3331 (analysis of product records).Investigation findings: 3221 (no findings available.Investigation conclusions: 67 (no problem detached).H10.Review of the dhr indicates qty (b)(4) were received on 05/05/2021 and passed inspection prior to being released into inventory.Review of complaints records indicate this is the only report for this pn and ln.No adverse trend identified.The product did not return for investigation.A root cause cannot be determined at this time.If additional information is provided, a supplemental report will be submitted.

• Brand Name: SAFEOP
• Common Device Name: IKD
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 1950 camino vida roble; carlsbad CA 92008
• MDR Report Key: 12021391
• Report Number: 2027467-2021-00040
• Device Sequence Number: 3910388
• Product Code: IKD
• UDI-Device Identifier: 00190376232287
• UDI-Public: 00190376232287
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: AIX1310-S
• Device Catalogue Number: AIX1310-S
• Device Lot Number: SH211052860
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/21/2021
• Supplement Date Received by Manufacturer: 05/21/2021
• Initial Report FDA Received Date: 06/17/2021
• Supplement Report FDA Received Date: 10/20/2021
• 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: Hospitalization