MAUDE Adverse Event Report: ACUMED LLC 3.5MM X 12MM LOCKING HEXALOBE SCREW; SCREW, FIXATION, BONE

Model Number 30-0234

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

Additional mdrs associated with this event: 3025141-2017-00087: plate, 3025141-2017-00089: screw 2, 3025141-2017-00090: screw 3, 3025141-2017-00091: screw 4, 3025141-2017-00092: screw 5, 3025141-2017-00093: screw 6, 3025141-2017-00094: screw 7, 3025141-2017-00095: drill 1, 3025141-2017-00096: drill 2.

Event Description

Surgeon reported that a patient may be having a reaction to an implanted clavicle plate.Surgeon later reported that "we can't be convinced that the implant is the cause of the rash".

• Brand Name: 3.5MM X 12MM LOCKING HEXALOBE SCREW
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): ACUMED LLC; 5885 nw cornelius pass road; hillsboro OR 97124 9432
• Manufacturer (Section G): ACUMED LLC; 5885 nw cornelius pass road; hillsboro OR 97124 9432
• Manufacturer Contact: micki lehman ; 5885 nw cornelius pass road; hillsboro, OR 97124-9432
• MDR Report Key: 6562920
• MDR Text Key: 75016288
• Report Number: 3025141-2017-00088
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 30-0234
• Device Catalogue Number: 30-0234
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other