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

Model Number AIX1310-S

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 05/21/2021

Event Type  Injury  

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 Description

There was an issue encountered while performing ptp with a doctor.

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
• Type of Device: IKD
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 1950 camino vida roble; carlsbad CA 92008
• MDR Report Key: 12021391
• MDR Text Key: 257132416
• Report Number: 2027467-2021-00040
• Device Sequence Number: 1
• Product Code: IKD
• UDI-Device Identifier: 00190376232287
• UDI-Public: 00190376232287
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AIX1310-S
• Device Catalogue Number: AIX1310-S
• Device Lot Number: SH211052860
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization