ARTHREX, INC. 4.5X28MM PERIPHERAL SCREW, NON-LOCKING; SHOULDER PROSTHESIS, REVERSE CONFIGURATION
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Model Number 4.5X28MM PERIPHERAL SCREW, NON-LOCKING |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Numbness (2415); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 10/01/2019 |
Event Type
Injury
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Manufacturer Narrative
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The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available, and without device evaluation.
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Event Description
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It was reported through the surgical outcome system that a patient may have had an issue as a result of surgery involving arthrex implants.Upon further investigation it was discovered that a patient had a (b)(6) 2019, reverse shoulder replacement procedure.After the nerve block had worn off, approximately 24 hours post surgery the patient was experiencing numbness in the surgical arm's palm, half of ring finger and the pinkie finger.The patient was diagnosed with ulnar nerve palsy, and told it may take a year to resolve.Patient consulted with a neurologist, who said nothing could be done.The ulnar nerve was damaged.No second surgery has been performed.The following are the arthrex products that were implanted on (b)(6) 2019: ar-9560 28-4 / lot: 6094; ar-9561-25p / lot: 5685; ar-9502f-39rcpc / lot: 19.00275; ar-9501-105 / lot: 18.0037; ar-9564-2839-lat / lot: 18.02027; ar-9562-28nl / lot: 2018005880; ar-9503m-06 / 19.00667; ar-9563-28 / lot: 2019001687; ar-9563-24 / lot: 19.02242; ar-9562-28nl / lot: 2018005880.
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