MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-11-10 for ANCHOR BOLT - LSB STYLE UNKNOWN manufactured by Ad-tech Medical Instrument Corporation.
[92659775]
As stated in the event description, (b)(6) from (b)(6) contacted ad-tech by email on (b)(6) 2017 regarding anchor bolts that broke. Two fractured anchor bolts were partially retrieved on an explant. This was a patient with non-convulsive seizures, and no overt trauma in the emu or theatre. One bolt was subsequently retrieved at craniotomy, another, in an uninvolved region, remains in situ. The products were not sent back to ad-tech for evaluation. Instead, a picture was sent showing the broken bolts. Based on the picture, the alleged deficiency in the complaint was confirmed. The investigation in still on-going.
Patient Sequence No: 1, Text Type: N, H10
[92659776]
On (b)(6) 2017 a customer contacted ad-tech via email regarding anchor bolts that broke. It was stated that two fractured anchor bolts were partially retrieved on an explant. This was a patient with non-convulsive seizures, and no overt trauma in the emu or theatre. The customer also stated that one bolt was subsequently retrieved at craniotomy. Another one, in an uninvolved region, remained in situ. There is no known impact to the patient. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183456-2017-00010 |
| MDR Report Key | 7022990 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-11-10 |
| Date of Report | 2017-11-10 |
| Date Mfgr Received | 2017-10-12 |
| Date Added to Maude | 2017-11-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. KATHLEEN BARLOW |
| Manufacturer Street | 1901 WILLIAM STREET |
| Manufacturer City | RACUNE WI 53404 |
| Manufacturer Country | US |
| Manufacturer Postal | 53404 |
| Manufacturer Phone | 2626341555 |
| Manufacturer G1 | AD-TECH MEDIAL INSTRUMENT CORPORATION |
| Manufacturer Street | 1901 WILLIAM STREET |
| Manufacturer City | RACINE WI 53404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANCHOR BOLT - LSB STYLE |
| Generic Name | ANCHOR BOLT - LSB STYLE |
| Product Code | GCZ |
| Date Received | 2017-11-10 |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AD-TECH MEDICAL INSTRUMENT CORPORATION |
| Manufacturer Address | 1901 WILLIAM STREET RACINE WI 53404 US 53404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-11-10 |