|
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Injury (2348); No Code Available (3191)
|
Event Type
Injury
|
Manufacturer Narrative
|
This report is for an unk - screws/unknown lot.Part and lot numbers are unknown; udi number is unknown.Reporter is jnj representative without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
This report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (drra) for patients undergoing cervical laminoplasty procedures.Failed cervical or thoracic spine fusion has been identified as the reported complication as per icd 9 & 10 categorization experienced by the following with corresponding intervention: 3 patients had reoperation within 90 days from the index surgery.5 patients had a revision surgery within 90 days from the index surgery.6 patients had a revision surgery within 12 months from the index surgery.7 patients had a revision surgery within 24 months from the index surgery.This is for depuy spine mountaineer laminoplasty system.This report is for (1) unknown screws this is report 4 of 8 for (b)(4).Related product complaint: (b)(4).(b)(4): unknown plates, (b)(4): unknown screws.These impacted products capture the reported reoperation within 90 days from the index surgery.(b)(4): unknown plates, (b)(4): unknown screws.These impacted products capture the reported revision surgery within 90 days from the index surgery.(b)(4): unknown plates, (b)(4): unknown screws.These impacted products capture the reported revision surgery within 12 months from the index surgery.(b)(4): unknown plates, (b)(4): unknown screws.These impacted products capture the reported revision surgery within 24 months from the index surgery.
|
|
Search Alerts/Recalls
|
|
|