MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION ¿DURAGEN SECURE DURAL REGENERATION MATRIX 7.5CM X 7.5CM (3IN X 3IN)¿; DURAL REPAIR

Catalog Number ¿DRM1033¿

Device Problem Device Expiration Issue (1216)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/29/2016

Event Type  Injury  

Event Description

The patient was implanted an expired duragen on (b)(6) 2016.The customer did not save the box that the duragen was packaged in but the foil wrapper was saved and it had a lot number of 105nb0319115.It was noticed towards the end of the surgery that this implanted duragen had an expiration date of nov 2015.The customer claimed that the expired duragen with lot number 105nb0319115 was packaged in a duragen box that had a lot number of 105na0346873 with a good expiration date.However, the customer couldn't verify since they did not save the box.There was no patient injury reported.It was reported by the integra sales representative that the customer ordered 2 boxes of duragen previously in aug 2015 and these duragens had an expiration date of nov 2015.Recently, the customer ordered 4 boxes on 16 jun 2016 of unexpired duragen ( drm1033, lot number: 105na0346873).Since the customer received this current order of 4 boxes, 3 boxes remain on their shelf in the hospital unused and 1 box was recently used for a different patient/surgery on (b)(6) 2016 with no issues reported.All current 4 boxes ordered were accounted for.Additional information has been requested and on 15 jul 2016, the following was provided by the customer: a (b)(6) female patient underwent a bilateral l4-s1 laminoforaminotomy.There was no injury reported.Medication (not specified) was given to the patient since the expired product was implanted.No revision was done; the duragen was not removed after implanted.Patient's current condition is stable.

Manufacturer Narrative

Integra has completed their internal investigation on 8/20/2016.The investigation included: the product was not returned for evaluation.The product was implanted in the patient, and no removal via revision surgery was necessary.Lots involved: 105nb0319115, product name: duragen secure dural regeneration matrix, release date: 03-mar-2015, expiry date: 30-nov-2015, ship date to rdc: 04-mar-2015, ((b)(4) pieces); 105na0346873, duragen secure dural regeneration matrix, 29-apr-2016, 31-mar-2017, 03-may-2016, ((b)(4) pieces).The reported product lot associated with this complaint for duragen secure is lot 105nb0319115.Per the complaint description, the customer implanted duragen lot# 105nb0319115 on 29-jun-2016 on the patient, however, it was noted at the end of the surgery that this implanted product was in a box labeled with duragen lot# 105na0346873.Lot # 105nb0319115 that was implanted on 29-jun-2016, expired on 30-nov-2015.Therefore, per the customer, an expired lot of duragen was implanted in the patient.This dhr review will cover the batch record review for both the complaint lot# 105nb0319115 as well as the lot on the outer box label, lot# 105na0346873.Lot# 105nb0319115.The nc/event log and batch record were reviewed for any ncs/events related to the finished lot, as well as the lots of the components used to manufacture the product.There were no events/ncs found.A query of the capa log revealed no capas implemented for duragen product mislabeled or incorrectly labeled and packaged, or, expired product sold in the past 12 months.Lot# 105na0346873.The nc/event log and batch record were reviewed for any ncs/events related to the finished lot, as well as the lots of the components used to manufacture the product.There were no ncs/events related to boxing, labeling, or expiry that could have contributed to the current complaint.A query of the capa log revealed no capas implemented for duragen product mislabeled or incorrectly labeled and packaged, or, expired product sold in the past 12 months.Based on the dhr reviews conducted for lots 105nb0319115 and 105na0346873, there is no indication that the production process of these lots have contributed to this complaint.A query of the complaint database for the timeframe of 29-jun-2015 ¿ 29-jun-2016 was performed using the keywords: ¿duragen¿ and ¿implant¿ and ¿expire¿ as well as ¿duragen¿ and ¿wrong¿ and ¿label¿.No additional complaints were found.A query was performed in the complaints database for lots 105nb0319115 and 105na0346873.As per the trending query, there are two complaints identified for duragen secure lot #105nb0319115 in the past 12 months (including the current complaint).Therefore, the calculated complaint rate is 0.0014%.The root cause is undetermined.A contributing cause of this complaint could be customer error.From the dhr review, there were no anomalies found in the manufacturing processes of duragen lots 105nb0319115 and 105na0346873, specifically related to packaging, labeling and boxing that could have led to this complaint.Additionally, there was no trend identified per the trend analysis for this complaint issue or the lot numbers involved; and the risk levels are acceptable per the risk assessment.Additionally, duragen lot 105nb0319115 was shipped entirely to (b)(4) on 04-mar-2015 (total of (b)(4) pieces); and lot 105na0346873 was shipped entirely to rdc on 03-may-2016 ((b)(4) pieces).The retains from both lots, were shipped to masy on the same ship dates as listed above.Therefore, there was more than a year time gap in between the ship dates from both product lots.It is highly unlikely that a mix-up occurred at the (b)(4) facility.There is no evidence to support there was an error in the labeling of the lots.If there was a possibility of swap at the hospital facility, it would likely be during the timeframe of 24-jun-2016 to 29-jun-2016, where the outer box from lot 105na0346873 got switched (left around and not discarded, during patient surgery on 24-jun-2016), with the foil pouch from lot 105nb0319115.No other clear facts are known at this time; therefore, the root cause cannot be determined.

• Brand Name: ¿DURAGEN SECURE DURAL REGENERATION MATRIX 7.5CM X 7.5CM (3IN X 3IN)¿
• Type of Device: DURAL REPAIR
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; 105 morgan lane; 105 morgan lane; plainsboro NJ 08536
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION; 105 morgan lane; plainsboro NJ 08536
• Manufacturer Contact: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5808358
• MDR Text Key: 49972975
• Report Number: 1121308-2016-00015
• Device Sequence Number: 1
• Product Code: GXQ
• Combination Product (y/n): N
• PMA/PMN Number: K120600
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ¿DRM1033¿
• Device Lot Number: 105NB0319115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/20/2016
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 47 YR